BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 3

    MDR report key: 2213072 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02769
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT THE NEEDLE WAS BENT AND THE JAWS MISALIGNED. NO ABNORMALITIES WERE NOTED WITH THE DEVICE RIVETING AND CRIMPING WHICH WERE WITHIN SPECIFICATIONS. FUNCTIONALLY, THE DEVICE JAWS WOULD OPEN, BUT FAILED TO CLOSE PROPERLY DUE TO THE BENT NEEDLE AND THE MISALIGNED JAWS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT; JAWS WON'T CLOSE. EVALUATION OF THE DEVICE ALSO FOUND THAT THE NEEDLE WAS BENT AND THE JAWS WERE MISALIGNED. SINCE THERE ARE CONTROLS IN THE MANUFACTURING PROCESS THAT VERIFY PRODUCT INTEGRITY, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. 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 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE DID NOT CLOSE COMPLETELY DURING THE INITIAL USE. NO DEVICE DAMAGE WAS NOTED AND NO BIOPSY SAMPLES WERE COLLECTED WITH THIS DEVICE PRIOR TO THE ALLEGED ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 SINGLE-USE BIOPSY FORCEPS WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE DID NOT CLOSE COMPLETELY DURING THE INITIAL USE. NO DEVICE DAMAGE WAS NOTED AND NO BIOPSY SAMPLES WERE COLLECTED WITH THIS DEVICE PRIOR TO THE ALLEGED ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW¿ 3 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515373 14378441

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR