BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2980866 · Received February 27, 2013

    Report

    Report Number
    3005099803-2013-01081
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/DATE OF BIRTH IS UNKNOWN; HOWEVER, THE PATIENT WAS REPORTED AS BEING OVER 18 YEARS OLD. EXACT PATIENT WEIGHT IS REPORTED TO BE (B)(6). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER COLLECTING A BIOPSY SAMPLE, THE NURSE NOTED SOME DIFFICULTY OPENING AND CLOSING FORCEPS AND A SLIGHT "BURR" ON END OF FORCEPS. REPORTEDLY THE PHYSICIAN EXAMINED THE FORCEPS BUT DID NOT SEE ANYTHING ABNORMAL, AND AFTER REPEATED OPENING AND CLOSING FORCEPS FUNCTIONED FINE AND BURR NO LONGER VISIBLE. THE FORCEPS DEICE WAS TAPPED INTO THE COLLECTION CONTAINER TO RELEASE TISSUE SPECIMEN. THE SPECIMEN WAS BEING EXAMINED BY PATHOLOGY WHEN THEY NOTED A PIECE OF METAL THAT WAS SURROUNDED BY THE TISSUE. THE COMPLAINANT REPORTED THAT THE PIECE OF METAL FOUND WAS NOT THE "BURR" SEEN DURING THE PROCEDURE AND THEY COULD NOT CONFIRM OR DENY WHETHER THE PIECE OF METAL ORIGINATED FROM THE FORCEPS. REPORTEDLY, THE PATIENT HAS HISTORY OF ERCP SPHINCTEROTOMY, AND EGD FOR POST SPHINCTEROTOMY BLEED. HOWEVER THE PATIENT DID NOT HAVE ANY SURGERY POST PROCEDURE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT, AND THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84733 RADIAL JAW¿ 3 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00515352 0015513636

    Patients

    Seq Age Sex Outcome Treatment
    1