BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 1802991 · Received August 17, 2010

    Report

    Report Number
    3005099803-2010-03601
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    July 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CAUTERY PLUG LEGS WERE CLOSER THAN USUAL. MEASUREMENT OF THE 2-IN-1 ACTIVE CORD CONNECTOR FOUND THAT THE OUTSIDE DIAMETER WAS OUT OF SPECIFICATION AND COULD CAUSE THE REPORTED ISSUE. FUNCTIONALLY THE RETURNED DEVICE WAS RESISTANCE TESTED AND IT PERFORMED WITHIN SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE CONNECTOR PIN WAS DEFECTIVE. THE MOST PROBABLE ROOT CAUSE IS A SUPPLIER MANUFACTURE ISSUE SINCE THE OUTSIDE DIAMETER OF THE 2-IN-1 ACTIVE CORD CONNECTOR WAS OUT OF SPECIFICATION. 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 HOT SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, IT WAS DETERMINED THAT THE ACTIVE CORD COULD NOT BE ATTACHED DUE TO AND ISSUE WITH THE CONTACT POST. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A BIOPSY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE, IT WAS DETERMINED THAT THE ACTIVE CORD COULD NOT BE ATTACHED DUE TO AND ISSUE WITH THE CONTACT POST. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS 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. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOT BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA M00515502 0012910599

    Patients

    Seq Age Sex Outcome Treatment
    1