BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1994019 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00472
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):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.(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. A SPECIFIC CAUSE OF THE ALLEGED FAILURE COULD NO BE IDENTIFIED, HOWEVER, THE DIRECTIONS FOR USE (DFU) CAUTIONS THE USER THAT A POTENTIAL EVENT IS BLEEDING, THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION. 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. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 BIOPSY FORCEPS WAS USED DURING AN OESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY WAS TAKEN FROM THE STOMACH CAUSING A MUCOUSAL BLEED. ADRENALINE WAS USED TO STOP THE BLEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. ADDITIONALLY, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 BIOPSY FORCEPS WAS USED DURING AN OESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE A BIOPSY WAS TAKEN FROM THE STOMACH CAUSING A MUCOUSAL BLEED. ADRENALINE WAS USED TO STOP THE BLEED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 3 BIOPSY FORCEPS. ADDITIONALLY, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. 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 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00515371 0013651162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention