Events

Rappel de OX LAPIMBGP1 ZESTAW DO MGBP

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par COVIDIEN MEDTRONIC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79974
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1844-2018
  • Date de mise en oeuvre de l'événement
    2018-04-26
  • Date de publication de l'événement
    2018-05-16
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164101
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Staple, implantable - Product Code GDW
  • Cause
    Device may be missing a sled component. the sled component is responsible for staple deployment. this may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
  • Action
    On April 26, 2108, all consignees were issued were issued Urgent Medical Device Recall notices and Return Forms via Federal Express or certified mail. On May 22, 2018, all consignees received an UPDATED URGENT MEDICAL DEVICE RECALL notice. The updated notice included NEW product which has been processed under FDA Ref # 80423. The notice informs customers of the potential for use of a device with a missing sled and the actions they should take to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. All in-control inventory and devices returned from customers will be reworked. **FOR INTERNATIONAL CUSTOMERS** Please be aware that the recalled units are packed within various convenience kits as identified on the Attachment B provided with your customer letter. Customers are also encouraged to EMAIL OR FAX THE ACKNOWLEDGEMENT FORM TO: - "Product purchased directly from Medtronic": feedback.customerservice@Covidien.com or fax to (800) 895-6140. - "Product purchased through distributor": FCAMITG@Covidien.com or fax it to (203) 492-7719.

Device

OX LAPIMBGP1 ZESTAW DO MGBP
  • Modèle / numéro de série
    Lots: 0214930629, 0214993038, 0215068848, 0215124286, 0215124285, 0214793818, 0215130759,0215243237
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide and US Nationwide
  • Description du dispositif
    OX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
    COVIDIEN MEDTRONIC

Manufacturer

COVIDIEN MEDTRONIC
  • Adresse du fabricant
    COVIDIEN MEDTRONIC, 60 NIDDLETOWN AVE 2ND F, NORTH HAVEN CT 06473
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA