BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEA,DSCTR 5MM BLUNT NOSE

    MDR report key: 368543 · Received December 21, 2001

    Report

    Report Number
    1219602-2001-00180
    Event Type
    Malfunction
    Date Received
    December 21, 2001
    Date of Event
    November 27, 2001
    Report Date
    December 20, 2001
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE SURGEON ATTEMPTED TO GRASP SOME TISSUE WITH A BLUNT NOSE INSTRUMENT. THE INSTRUMENT WOULD NOT OPEN, AS A RESULT, A BACKUP DEVICE HAD TO BE USED. FOLLOWING INVESTIGATION OF THE INSTRUMENT THAT WOULD NOT OPEN IT WAS DISCOVERED BY THE OR PERSONNEL THAT A PIVOT PIN WAS MISSING. THE SURGEON WAS UNSURE IF THE PIVOT PIN MAY STILL REMAIN IN THE PATIENT. NO PATIENT INJURY OR PROCEDURAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58243 FEA,DSCTR 5MM BLUNT NOSE * HRX SMITH & NEPHEW, INC., ENDOSCOPY DIVISION NA 464384

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN