BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIATURE BIOPSY FORCEPS

    MDR report key: 5596302 · Received April 21, 2016

    Report

    Report Number
    9610617-2016-00073
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    February 3, 2016
    Report Date
    March 25, 2016
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    GCJ
    PMA / PMN Number
    K940594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    WE ARE FILING THIS SUPPLEMENTAL FOR 2 REASONS: WE LISTED THE PART NUMBER OF THE DEVICE AS 27290M; IT WAS ACTUALLY A 27071ZJ. THE COPY OF THE CUSTOMER'S MDR THAT WE REC'D FROM THE FDA DID NOT HAVE A PART NUMBER LISTED. WE LEARNED OF IT LATER. UPON DETERMINING THE CORRECT PART NUMBER, WE ALSO REALIZED WE HAD ALREADY FILED ON THIS EVENT: WE FILED 9610617-2016-19 ON 3/11/16 (OUR FILE: (B)(4)). CORE ID FROM 2ND ACKNOWLEDGEMENT ON MDR 16-19: COREID: (B)(6). SO 16-73 IS A DUPLICATE OF 16-19. I CORRECTED THIS MDR WHICH WILL INCLUDE THE CORRECT PART NUMBER, PRODUCT DESCRIPTION, PRODUCT DEVICE CODE AND 510K NUMBER FOR 27071ZJ. PLEASE CONSIDER THIS A DUPLICATE OF THE MDR FILED PREVIOUSLY ON THIS EVENT. DEVICE NOT RETURNED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    ALLEGEDLY, THE DOCTOR WAS PERFORMING A UROLOGY PROCEDURE WHEN THE DOCTOR NOTED THAT A METAL PIECE BROKE OFF THE INSTRUMENT AND FELL INTO THE PATIENT'S BLADDER. THE DOCTOR IMMEDIATELY USED ANOTHER GRASPING FORCEPS TO REMOVE THE BROKEN PIECE. THE BLADDER WAS IRRIGATED THOROUGHLY AND AN X-RAY WAS TAKEN TO CONFIRM THAT NOTHING WAS LEFT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND NO SERIOUS INJURY TO PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    WE ARE FILING THIS SUPPLEMENTAL FOR 2 REASONS: WE LISTED THE PART NUMBER OF THE DEVICE AS 27290M; IT WAS ACTUALLY A 27071ZJ. THE COPY OF THE CUSTOMER'S MDR THAT WE REC'D FROM THE FDA DID NOT HAVE A PART NUMBER LISTED. WE LEARNED OF IT LATER. UPON DETERMINING THE CORRECT PART NUMBER, WE ALSO REALIZED WE HAD ALREADY FILED ON THIS EVENT: WE FILED 9610617-2016-19 ON 3/11/16 (OUR FILE: 16-19, 16-939194-19). CORE ID FROM 2ND ACKNOWLEDGEMENT ON MDR 16-19: COREID: (B)(6). SO 16-73 IS A DUPLICATE OF 16-19. I CORRECTED THIS MDR WHICH WILL INCLUDE THE CORRECT PART NUMBER, PRODUCT DESCRIPTION, PRODUCT DEVICE CODE AND 510K NUMBER FOR 27071ZJ. PLEASE CONSIDER THIS A DUPLICATE OF THE MDR FILED PREVIOUSLY ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251173 MINIATURE BIOPSY FORCEPS MINIATURE BIOPSY FORCEPS GCJ KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 27071ZJ FL

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention