BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 2093472 · Received May 18, 2011

    Report

    Report Number
    3005099803-2011-01783
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER REPORTED TO BE (B)(6). (B)(4), (JAWS WON'T CLOSE). 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 FOUND NO ABNORMALITIES AND THE DEVICE WAS WITHIN SPECIFICATIONS. SIMILARLY, THE RETURNED UNIT WAS FUNCTIONALLY TESTED AND IT PERFORMED ACCORDING TO SPECIFICATIONS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT; THAT THE DEVICE WONT CLOSE. THE MOST PROBABLE ROOT CAUSE COULD NOT BE CONFIRMED AS THE RETURNED DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUPS OF THE DEVICE DID NOT OPEN AND CLOSE SMOOTHLY. WHEN THE DEVICE WAS REMOVED FROM THE SCOPE, THE CUPS DID NOT CLOSE PROPERLY AND WERE MISALIGNED. REPORTEDLY, THERE WAS NO DIFFICULTY OR RESISTANCE FELT WHILE INSERTING OR REMOVING THE DEVICE THOUGH THE SCOPE, AND THERE WAS NO OTHER DEVICE DAMAGE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. NO BIOPSY SAMPLES HAD BEEN COLLECTED WITH THE COMPLAINT DEVICE PRIOR TO THE ALLEGED FAILURE. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUPS OF THE DEVICE DID NOT OPEN AND CLOSE SMOOTHLY. WHEN THE DEVICE WAS REMOVED FROM THE SCOPE, THE CUPS DID NOT CLOSE PROPERLY AND WERE MISALIGNED. REPORTEDLY, THERE WAS NO DIFFICULTY OR RESISTANCE FELT WHILE INSERTING OR REMOVING THE DEVICE THOUGH THE SCOPE, AND THERE WAS NO OTHER DEVICE DAMAGE NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY DEVICE. NO BIOPSY SAMPLES HAD BEEN COLLECTED WITH THE COMPLAINT DEVICE PRIOR TO THE ALLEGED FAILURE. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513381 13936909

    Patients

    Seq Age Sex Outcome Treatment
    1