BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS GRASPER

    MDR report key: 167520 · Received May 15, 1998

    Report

    Report Number
    1921846-1998-00013
    Event Type
    Injury
    Date Received
    May 15, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 16, 1998
    Manufacturer
    ACUFEX MICROSURGICAL, INC
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. COMPLAINT #0V1998-4-17-122. DEVICE WAS RETURNED AND EVALUATED. CO NOTED THAT THE NYLON SPACER AND SEAL WERE MISSING ON THE DRIVE SHAFT. HEAT SHRINK TUBING HAD BEEN APPLIED ON THE DRIVE SHAFT NEAR THE DISTAL END. THIS IS NOT AN ACCEPTABLE PRACTICE. CUSTOMER REPORTS THEY HAVE HAD THE DEVICE REPAIRED BY AN OUTSIDE VENDOR. PRODUCT FAILURE IS MOST LIKELY A RESULT OF THE UNAUTHORIZED REPLACEMENT OF NYLON SPACER AND SEAL. LOT HISTORY REVIEW WAS UNREMARKABLE WITH REGARD TO THE COMPLAINT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED AGAINST THIS LOT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, "LAPARASCOPIC GRASPER BROKE OFF INTO PT DURING SURGERY. THIS COMPONENT WAS REPAIRED THREE TIMES BY REPAIR CENTER. PT STILL HAS PIECE INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS GRASPER LAPAROSCOPIC SURGICAL INSTRUMENT GCJ ACUFEX MICROSURGICAL, INC NA L884108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention