BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW¿ 4

    MDR report key: 3010003 · Received March 18, 2013

    Report

    Report Number
    3005099803-2013-01509
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE JACKET OF THE SHAFT WAS PEELED WITH THE COIL UNDERNEATH EXPOSED. THE DEVICE WELDING AND RIVETING WERE FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. FUNCTIONALLY, THE UNIT WAS ABLE TO BE OPENED AND CLOSED WITHOUT ISSUE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE JACKET OF THE SHAFT WAS PEELED. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE HANDLING 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 4 GASTROPEDIATRIC SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A STOMACH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, THE PHYSICIAN CHECKED THE DEVICE AND NOTICED THAT THE JACKET OF THE SHAFT WAS PEELED. NO OTHER DEVICE DAMAGE OR ANOMALY WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 GASTROPEDIATRIC SINGLE-USE BIOPSY FORCE DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 GASTROPEDIATRIC SINGLE-USE BIOPSY FORCEPS WAS TO BE USED DURING A STOMACH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING UNPACKING FOR THE PROCEDURE, THE PHYSICIAN CHECKED THE DEVICE AND NOTICED THAT THE JACKET OF THE SHAFT WAS PEELED. NO OTHER DEVICE DAMAGE OR ANOMALY WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 GASTROPEDIATRIC SINGLE-USE BIOPSY FORCE DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS BEING STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112574 RADIAL JAW¿ 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00513441 0015499729

    Patients

    Seq Age Sex Outcome Treatment
    1