Events

Recall of SURGICAL TROCARS - SEPARATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by APPLIED MEDICAL RESOURCES CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32094
  • Event Risk Class
    II
  • Event Initiated Date
    2009-07-20
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A cannula tip had fractured during a gastric bypass procedure. the resulting fragments were recovered and the event did not directly result in patient injury. however the surgeon converted the laparoscopic procedure to "open" to confirm all fragments were recovered. the identity of other medical devices or accessories used in the event is unknown.

Device

SURGICAL TROCARS - SEPARATOR
  • Model / Serial
    Model Catalog: C0R36 (Lot serial: 1082348); Model Catalog: C0R36 (Lot serial: 1084426); Model Catalog: C0R36 (Lot serial: 1085506)
  • Product Description
    C0R36 15x100mm Kii Optical Access Sys
  • Manufacturer
    APPLIED MEDICAL RESOURCES CORPORATION

Manufacturer

APPLIED MEDICAL RESOURCES CORPORATION