BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPSY FORCEPS

    MDR report key: 1902772 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04735
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EOQ
    PMA / PMN Number
    K895415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT A PIECE OF THE JACKET WAS PROTRUDING FROM THE RETURNED DEVICE. THE DEVICE RIVETING AND CRIMPING MARKS WERE WITHIN SPECIFICATION. FUNCTIONALLY, THE DEVICE OPENED AND CLOSED WITHIN SPECIFICATION. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE JACKET WAS DAMAGED. THE EVALUATION FOUND THAT THE JACKET WAS PROTRUDING FROM THE DEVICE DISTAL END WHICH IS INDICATIVE OF A TRIMMING ISSUE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT ID, AGE, GENDER AND WEIGHT ARE UNKNOWN. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF 2 DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-04736, FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS THE BIOPSY FORCEPS WERE WITHDRAWN FROM THE SCOPE, IT WAS NOTED THAT A PART OF THE BLUE COATING PEELED OFF OF THE DEVICE. THE PHYSICIAN SEARCHED FOR ANY FRAGMENTS IN THE PATIENT AND ENDOSCOPE AND FOUND NONE. THE PROCEDURE WAS COMPLETED WITH A SECOND BIOPSY FORCEPS DEVICE. THE SAME ISSUE (COATING PEELED) OCCURED WITH THE SECOND DEVICE. AGAIN, THE PHYSICIAN SEARCHED FOR FRAGMENTS AND FOUND NONE. 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 STABLE. ALTHOUGH THE COATING FRAGMENTS COULD NOT BE LOCATED, THE PHYSICIAN WAS NOT CONCERNED ABOUT THE POTENTIAL OF FRAGMENTS IN THE PATIENT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF 2 DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-04736, FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BIOPSY FORCEPS WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AS THE BIOPSY FORCEPS WERE WITHDRAWN FROM THE SCOPE, IT WAS NOTED THAT A PART OF THE BLUE COATING PEELED OFF OF THE DEVICE. THE PHYSICIAN SEARCHED FOR ANY FRAGMENTS IN THE PATIENT AND ENDOSCOPE AND FOUND NONE. THE PROCEDURE WAS COMPLETED WITH A SECOND BIOPSY FORCEPS DEVICE. THE SAME ISSUE (COATING PEELED) OCCURED WITH THE SECOND DEVICE. AGAIN, THE PHYSICIAN SEARCHED FOR FRAGMENTS AND FOUND NONE. 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 STABLE. ALTHOUGH THE COATING FRAGMENTS COULD NOT BE LOCATED, THE PHYSICIAN WAS NOT CONCERNED ABOUT THE POTENTIAL OF FRAGMENTS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY FORCEPS BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - COSTA RICA M00515230 13307177

    Patients

    Seq Age Sex Outcome Treatment
    1