BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1905084 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04877
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, GENDER AND WEIGHT ARE UNKNOWN. THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER IT WAS REPORTED THAT HE PATIENT IS OVER 18 YEARS. 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).

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICE WAS WITHIN SPECIFICATION; HOWEVER THE NEEDLE WAS BENT. A FUNCTIONAL EVALUATION CONFIRMED THAT THE DEVICE WAS ABLE TO OPEN, BUT DID NOT CLOSE PROPERLY DUE TO THE BENT NEEDLE. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE NEEDLE BENT. BASED ON THE CONDITION OF THE RETURNED DEVICE, AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE DUE TO ANATOMICAL OR PROCEDURAL FACTORS LIMITING THE DEVICE PERFORMANCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE RADIAL JAW 3 BIOPSY FORCEPS WERE USED TO SUCCESSFULLY OBTAIN TWO GASTRIC BIOPSIES. THE BIOPSY SPECIMENS WERE PLACED INTO THE SPECIMEN JAR. THE FORCEPS WERE THEN REINTRODUCED INTO THE PATIENT AND POSITIONED WITHIN THE ESOPHAGUS. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO OBTAIN AN ESOPHAGEAL BIOPSY, IT WAS DISCOVERED THAT THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE RADIAL JAW 3 BIOPSY FORCEPS WERE USED TO SUCCESSFULLY OBTAIN TWO GASTRIC BIOPSIES. THE BIOPSY SPECIMENS WERE PLACED INTO THE SPECIMEN JAR. THE FORCEPS WERE THEN REINTRODUCED INTO THE PATIENT AND POSITIONED WITHIN THE ESOPHAGUS. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO OBTAIN AN ESOPHAGEAL BIOPSY, IT WAS DISCOVERED THAT THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. 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 3 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515373 0013722502

    Patients

    Seq Age Sex Outcome Treatment
    1