BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGLED ARTICULATING TRIANGULAR RETRACTOR, 80CM

    MDR report key: 13111272 · Received December 28, 2021

    Report

    Report Number
    MW5106324
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 24, 2021
    Manufacturer
    SNOWDEN PENCER V. MUELLER, BD CAREFUSION 2200, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5106324 ON 01/26/2022. MODEL NUMBER WAS INCORRECTLY REPORTED IN FDA REPORT #MW5106324. MODEL# HAS BEEN CORRECTED FROM 89-6105 TO 89-6112.

    Description of Event or Problem · 0

    FIRST ASSIST WAS HOLDING THE SNAKE LIVER RETRACTOR DURING PROCEDURE WHEN IT BROKE. THE WIRE SPLIT AND THE SMALL CYLINDRICAL METAL PIECES CAME OFF THE WIRE AND INTO THE PATIENT'S ABDOMINAL CAVITY. ALL PIECES REMOVED BY SURGEON. X-RAY PERFORMED AND READ BY RADIOLOGY. NO SIGN OF METAL LEFT IN THE PATIENT. INSTRUMENT MANUFACTURED BY SNOWDEN PENCER #89-6105. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000108 ANGLED ARTICULATING TRIANGULAR RETRACTOR, 80CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SNOWDEN PENCER V. MUELLER, BD CAREFUSION 2200, INC. 89-6112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention