BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1880621 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04396
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THIS ADDITIONAL INFORMATION REVEALING THAT NO INTERVENTION (MEDICAL OR SURGICAL) WAS NEEDED TO STOP THE BLEEDING, THIS REPORT IS NOW CONSIDERED A NON-REPORTABLE EVENT. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED AND A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER, REPORTED TO BE UNDER 18 YEARS OLD. (B)(4) - (INTERVENTION REQUIRED TO STOP BLEED). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (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 A BIOPSY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, FOUR BIOPSY SAMPLES WERE COLLECTED (TWO FROM THE FUNDUS AND TWO FROM THE ANTRUM). DURING THE FOURTH BIOPSY SAMPLING, THE MUCOSA WAS NOT CUT PROPERLY. CONSEQUENTLY A 6MM MUCOSAL TEAR OCCURRED AND BLEEDING TRANSPIRED FOR APPROXIMATELY TWO MINUTES. NO SURGICAL INTERVENTION WAS NEEDED. THE PROCEDURE WAS COMPLETED WITH A RADIAL JAW 3 BIOPSY FORCEPS DEVICE. THE DEVICE WAS INSPECTED/TESTED PRIOR TO USE AND NO ANOMALIES WERE NOTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED FREQUENT GASTROESOPHAGEAL REFLUX DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. BOSTON SCIENTIFIC CORPORATION WILL ASSUME THAT ALTHOUGH SURGICAL INTERVENTION WAS REPORTED AS NOT NEEDED, MEDICAL INTERVENTION MAY HAVE BEEN PERFORMED TO STOP THE INTRAPROCEDURAL BLEEDING. THEREFORE, THIS REPORT WILL BE CONSIDERED AN ADVERSE EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE AMOUNT OF BLEEDING WAS 99ML AND STOPPED SPONTANEOUSLY. THE ACCOUNT FURTHER CLARIFIED THAT NO SURGICAL OR MEDICAL INTERVENTION WAS PERFORMED TO EITHER STOP THE BLEEDING OR CORRECT THE TISSUE TEAR. ADDITIONALLY, THE PHYSICIAN SAW THE PATIENT DURING A FOLLOW-UP ON (B)(6), 2010 AND REPORTED HER CONDITION AS BEING FINE.

    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 M00513401 0013573955

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention