Events

Rappel de Device Recall Valleylab Laparoscopic Handset

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
    76384
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1836-2017
  • Date de mise en oeuvre de l'événement
    2017-01-26
  • 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=153021
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Customer reports of the device handset continuing to operate after release of the activation button.
  • Action
    A recall was initiated on January 26, 2017. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices: Will be reworked.

Device

Device Recall Valleylab Laparoscopic Handset
  • Modèle / numéro de série
    E2750: 52990142X 52990142X 52990144X 52990144X 52990147X 52990147X 52990151X 52990151X 53250057X 53250057X 53250061X 53250061X 53250063X 53250063X 53250065X 53250065X 53610053X 53610053X 53610055X 53610055X 53610059X 53610059X 53610061X 53610061X 60240055X 60240055X 60240059X 60240059X 60240061X 60240061X 60240065X 60240065X 60520098X 60520098X 60520104X 60520104X 60870064X 60870064X 61220093X 61220093X 61220095X 61220095X 61220098X 61220098X 61300164X 61300164X 61540145X 61540145X 61540150X 61540150X E2750NSB: 52990145X 53250066X 61220096X 61540146X
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide - US Nationwide Distribution in the states of: AR AZ CA CO FL GA IA IL KS KY LA MA MI MN MO MS NC NE NM NY OH OR PA SC SD TN TX VA WA WV
  • Description du dispositif
    Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB || Product Usage: || For use in 5mm cannulas or larger cannulas with 5mm adapters during laparoscopic and thorascopic procedures. For use with a minimum peak voltage of 3625V.
  • Manufacturer
    COVIDIEN MEDTRONIC

Manufacturer

COVIDIEN MEDTRONIC
  • Adresse du fabricant
    COVIDIEN MEDTRONIC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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