BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW? 4

    MDR report key: 3150153 · Received June 6, 2013

    Report

    Report Number
    3005099803-2013-04536
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION FOUND NO ISSUE WITH THE DEVICE. THERE WERE NO MANUFACTURING ISSUES FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD. THE ORIGIN OF THE FOREIGN MATERIAL IS UNKNOWN, BUT IT WAS LIKELY RESIDUAL FROM THE CUSTOMER¿S ENDOSCOPE, OR WAS INTRODUCED INTO THE RADIAL JAW DEVICE FROM THE PATIENT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PACKAGING OF THE DEVICE WAS NOT DAMAGED AND THE STERILE BARRIER WAS NOT COMPROMISED. THE FORCEPS WERE TIGHTLY CLOSED WHEN ADVANCED THROUGH THE SCOPE, AND THERE WAS NO ISSUE WHILE ADVANCING THE FORCEPS THROUGH THE SCOPE. AFTER THE FORCEPS EXITED THE SCOPE, WHEN THE PHYSICIAN OPENED THE FORCEPS TO TAKE A BIOPSY SAMPLE, IT WAS NOTICED THAT THERE WAS A FOREIGN BODY INSIDE THE CUP OF THE FORCEP. THE FORCEPS WERE IMMEDIATELY CLOSED AND REMOVED FROM THE SCOPE. IT WAS REPORTED THAT THE FOREIGN OBJECT LOOKED LIKE A PIECE OF TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS. 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 "OKAY".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PACKAGING OF THE DEVICE WAS NOT DAMAGED AND THE STERILE BARRIER WAS NOT COMPROMISED. THE FORCEPS WERE TIGHTLY CLOSED WHEN ADVANCED THROUGH THE SCOPE, AND THERE WAS NO ISSUE WHILE ADVANCING THE FORCEPS THROUGH THE SCOPE. AFTER THE FORCEPS EXITED THE SCOPE, WHEN THE PHYSICIAN OPENED THE FORCEPS TO TAKE A BIOPSY SAMPLE, IT WAS NOTICED THAT THERE WAS A FOREIGN BODY INSIDE THE CUP OF THE FORCEP. THE FORCEPS WERE IMMEDIATELY CLOSED AND REMOVED FROM THE SCOPE. IT WAS REPORTED THAT THE FOREIGN OBJECT LOOKED LIKE A PIECE OF TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS. 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 "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251008 RADIAL JAW? 4 FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00513412 0015882046

    Patients

    Seq Age Sex Outcome Treatment
    1