BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOT BIOPSY FORCEPS

    MDR report key: 2402860 · Received January 6, 2012

    Report

    Report Number
    3005099803-2011-04553
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Report Date
    December 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT DID NOT PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. THE REPORTED EVENT: SYSTEM FAILED TO DELIVER ENERGY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-04548, 3005099803-2011-04549, AND 3005099803-2011-04550 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN ENDOSTAT III ELECTROSURGICAL UNIT, AN ENDOSTAT FOOT SWITCH, AN ACTIVE CORD, AND A POLYPECTOMY SNARE WERE USED DURING A PROCEDURE. IT IS UNKNOWN IF THE ACTIVE CORD AND SNARE WERE BSC PRODUCTS. ACCORDING TO THE COMPLAINANT, THE SYSTEM FAILED TO DELIVER ENERGY. IT WAS REPORTED THAT THE SNARE HAD NOT BEEN EXTENDED FAR ENOUGH OUT OF THE SCOPE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING 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

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #S 3005099803-2011-04548 AND 3005099803-2011-04549 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION (BSC) THAT AN ENDOSTAT III ELECTROSURGICAL UNIT, AN ENDOSTAT FOOT SWITCH, AND BSC HOT BIOPSY FORCEPS WERE USED DURING A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SYSTEM FAILED TO DELIVER ENERGY. HOWEVER, THE CLINICAL COORDINATOR AT THE ACCOUNT REPORTED THAT SHE WAS "VERY SURE" THAT THE BIOPSY FORCEPS HAD NOT BEEN EXTENDED FAR ENOUGH OUT INTO THE PATIENT'S COLON, CAUSING THE DEVICE TO GROUND ON THE SCOPE. THIS RESULTED IN INCONSISTENT CAUTERY, WHICH SHE BELIEVED TO HAVE BEEN THE CAUSE OF THE LACK OF CAUTERY THAT WAS INITIALLY REPORTED. THE PROCEDURE WAS ULTIMATELY COMPLETED USING THE SAME PROCEDURE SETUP ONCE THE FORCEPS HAD BEEN ADEQUATELY EXTENDED. 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 HOT BIOPSY FORCEPS FORCEPS, BIOPSY, ELECTRIC KGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK184

    Patients

    Seq Age Sex Outcome Treatment
    1