Events

Alerte De Sécurité sur Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ’75, and Pereyra-Raz Ligature Carrier

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Cook Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2017-04-25
  • Date de publication de l'événement
    2017-04-25
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170425.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: cook medical stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stamey needle, clarke-reich laparoscopic knot pusher, endoscopic introducer/extractor, pereyra ligature carrier ’75, and pereyra-raz ligature carrier. [catalogue identifiers: 1) j-syn-931630, j-syn-931615, j-syn-931600, 095030, 095015, 095000; 2) j-crkp-042900; 3) j-eie-051500; 4) j-plc-751810, 090100; 5) j-rsn-901600, 090002; lot numbers: all ]. the manufacturer has identified the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. their preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance. there have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilization associated with these devices. potential adverse events that may occur if the products are not adequately reprocessed include localized surgical site infection to deeper organ space infection as well as chemical residual exposure. the manufacturer advises users to examine inventory immediately to determine if they have affected products and quarantine affected products. return or discard any affected products. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 april 2017.

Device

Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Li...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cook Medical Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier ’75, and Pereyra-Raz Ligature Carrier
  • Manufacturer
    Cook Medical

Manufacturer

Cook Medical