BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 2070819 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01402
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT A JAW HAD BROKEN OFF AND WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY THE DEVICE NEEDLE WAS SEEN BENT. THE FRACTURED PART WAS SENT FOR MATERIAL ANALYSIS, AND IT WAS DETERMINED THAT THE FRACTURED SURFACE EXHIBITED COMPRESSION AND TENSION ZONES INDICATIVE OF BENDING OVERLOAD. NO MATERIAL ANOMALIES WERE NOTED. FUNCTIONALLY, THE RETURNED UNIT WAS NOT TESTED DUE TO THE SAMPLE RETURN CONDITION. THE DEVICE WELDING AND RIVETING WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; JAW DETACHMENT. BASED ON THE MATERIAL ANALYSIS, THE FRACTURE LIKELY OCCURRED DUE TO A BENDING OVERLOAD. ADDITIONALLY, THE DIRECTIONS FOR USE (DFU) CAUTION THAT THE "APPLICATION OF EXCESSIVE FORCE TO THE FORCEPS MAY DAMAGE THE DEVICE." THEREFORE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS WHICH CAUSED THE JAW TO FRACTURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, 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 .ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE JAWS FELL OFF INSIDE THE PATIENT. THE COMPONENT WAS RETRIEVED WITH A SECOND RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE, WHICH WAS ALSO USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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 . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE OF THE JAWS FELL OFF INSIDE THE PATIENT. THE COMPONENT WAS RETRIEVED WITH A SECOND RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS DEVICE, WHICH WAS ALSO USED TO COMPLETE THE PROCEDURE. 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515373 0013951639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention