BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-FIT PK SYSTEM

    MDR report key: 1477400 · Received August 26, 2009

    Report

    Report Number
    3001967056-2009-00001
    Event Type
    Malfunction
    Date Received
    August 26, 2009
    Date of Event
    July 21, 2009
    Report Date
    August 24, 2009
    Manufacturer
    NETWORK MEDICAL PRODUCTS LTD.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (3) OTHER ULTRA-FIT PK SYSTEM PRODUCTS WERE ALSO REPORTED BY THE SAME DOCTOR. MODEL / CATALOG# 11840-775, LOT#: 081442, EXPIRATION DATE: 09/30/2011, DATE OF MANUFACTURE: 09/2008. MODEL / CATALOG#: 11840-800, LOT# 081916, EXPIRATION DATE: 11/30/2011, DATE OF MANUFACTURE: 11/2008. MODEL / CATALOG#: 11840-800, LOT#: 081577, EXPIRATION DATE: 10/31/2011, DATE OF MANUFACTURE: 10/2008. FOLLOWING A FULL EVALUATION OF THE TREPHINES RETURNED, AN ASSESSMENT OF ADDITIONAL INFORMATION RECEIVED FROM ANGIOTECH AND INFORMATION COLLATED IN-HOUSE, WE BELIEVE THAT THE PRODUCT SUPPLIED TO ANGIOTECH IN THE PERIOD AUGUST 2008 - TO THE PRESENT IS SAFE FOR USE IN ALL NORMAL OPERATING CONDITIONS. COMPLAINTS HAVE BEEN LIMITED TO THOSE RECEIVED FROM ANGIOTECH AND IN PARTICULAR TO THOSE RECEIVED FROM ONE PARTICULAR TO THOSE RECEIVED FROM ONE PARTICULAR HOSPITAL, WHERE IT HAS TO BE SPECULATED THAT THE ATTACHMENT OF THE CAPSTAN WAS BEING TESTED BEFORE THE TREPHINE WAS TO BE USED. THE USE OF VARYING DEGREES OF 'FORCE' REMOVE A CAPSTAN, IS NOT CONSIDERED TO BE REASONABLE ANTICIPATED MISUSE OF THE DEVICE. AS THE SAFETY OF THE PATIENT IS PARAMOUNT IT IS THOUGHT PRUDENT TO TAKE CORRECTIVE AND PREVENTATIVE ACTIONS TO SATISFY THE REQUIREMENTS OF THE PARTICULAR DOCTOR INVOLVED. (B)(4). CAPSTANS WITH THE LOCK AND KEY CORRECTLY LOCATED DO NOT REQUIRE A STRONG ADHESIVE BOND TO HOLD THE WEIGHT OF THE TREPHINE OR TO PROGRESS THE BLADE DOWNWARDS OR UPWARDS. OF THE TREPHINES RETURNED AND TESTED BY NETWORK MEDICAL IT IS NOT THOUGHT THAT ANY OF THE CAPSTANS WOULD HAVE BECOME DETACHED DURING A PROCEDURE CARRIED OUT IN NORMAL OPERATING CONDITIONS. (B)(4).

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS ESTIMATED. THE DOCTOR REPORTED THAT DURING AN OPHTHALMIC PROCEDURE, EXTRA ANESTHESIA TIME WAS REQUIRED DUE TO DEFECTIVE TREPHINE PRODUCTS. THE PROCEDURE WAS DELAYED SO THAT REPLACEMENT PRODUCTS COULD BE LOCATED. POTENTIAL SAFETY ISSUES COULD ARISE FROM ADDITIONAL TIME UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA-FIT PK SYSTEM CORONET VACUUM TREPHINE FRO NETWORK MEDICAL PRODUCTS LTD. 11840-775 081703

    Patients

    Seq Age Sex Outcome Treatment
    1