BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI BITE BIOPSY FORCEPS

    MDR report key: 1971182 · Received January 26, 2011

    Report

    Report Number
    3005099803-2011-00159
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE RETURNED DEVICE WAS WITHIN SPECIFICATION. FUNCTIONALLY, THE DEVICE WAS ABLE TO BE OPENED AND CLOSED WITHIN MANUFACTURING SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE JAWS WOULD NOT CLOSE. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE COMPLAINT WAS NOT CONFIRMED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. 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 MULTIBITE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. DURING THE PROCEDURE A BIOPSY WAS COLLECTED FROM THE RIGHT COLON. THEY WERE UNABLE TO CLOSE THE BIOPSY FORCEPS COMPLETELY IN ORDER TO WITHDRAW THE DEVICE FROM THE SCOPE. THE PHYSICIAN THEN SHOOK THE SAMPLE OUT OF THE JAWS, SQUEEZED THE HANDLE OF THE FORCEPS AND PULLED THE FORCEPS FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MULTIBITE 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 MULTIBITE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. DURING THE PROCEDURE A BIOPSY WAS COLLECTED FROM THE RIGHT COLON. THEY WERE UNABLE TO CLOSE THE BIOPSY FORCEPS COMPLETELY IN ORDER TO WITHDRAW THE DEVICE FROM THE SCOPE. THE PHYSICIAN THEN SHOOK THE SAMPLE OUT OF THE JAWS, SQUEEZED THE HANDLE OF THE FORCEPS AND PULLED THE FORCEPS FROM THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MULTIBITE 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 MULTI BITE BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00510121 12910339

    Patients

    Seq Age Sex Outcome Treatment
    1