BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2031900 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01005
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. HOWEVER THE PATIENT WAS REPORTED TO BE (B)(6). THE EXACT EVENT DATE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PROCEDURE TOOK PLACE SOMETIME BETWEEN THE (B)(6), 2011. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION THE DEVICE WAS TESTED AND THE JAWS WOULD NOT CLOSE COMPLETELY. DURING THE PROCEDURE THE PHYSICIAN REPORTED THAT THE RADIAL JAWS TOOK BAD BITES AND BAD SPECIMENS. THE PHYSICIAN FELT THAT THE RADIAL JAWS WERE TEARING THE TISSUE INSTEAD OF CUTTING THE TISSUE. NO PATIENT BLEEDING WAS REPORTED. THE CASE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513412

    Patients

    Seq Age Sex Outcome Treatment
    1