BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER POLYPECTOMY SNARE

    MDR report key: 5800377 · Received July 16, 2016

    Report

    Report Number
    3007305485-2016-00086
    Event Type
    Malfunction
    Date Received
    July 16, 2016
    Date of Event
    June 13, 2016
    Report Date
    August 11, 2016
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FDI
    PMA / PMN Number
    K820430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, CONMED HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON COMPLETION OF THE COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AS REPORTED, DUE TO CONTAMINATION, THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE USED/DAMAGED OPTIMIZER SNARE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWS THE LOOP HAS DETACHED FROM THE DEVICE. IN THIS INSTANCE, WITHOUT ACTUAL PRODUCT, THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED THEREFORE, THE ROOT CAUSE OF THE REPORTED BREAKAGE CANNOT BE DETERMINED. THIS LOT WAS MANUFACTURED ON 28-AUG-2015. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT FOUND NO NCR'S AND NO NOTE OF DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO REPORTED BREAKAGE. OF THE LOT CONTAINING (B)(4)UNITS, THERE WERE 4 COMPLAINTS RECEIVED FROM THE SAME FACILITY FOR DETACHMENT OF COMPONENTS. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF 14 REPORTABLE EVENTS (INCLUDING THIS ONE) WITH A TOTAL OF 16 UNITS FOR DEVICE BREAKAGE. DURING THIS SAME 2-YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS REPORTED FAILURE MODE 0.004 PERCENT. THIS FAILURE MODE IS ADDRESSED IN THE RISK DOCUMENT WITH AN ACCEPTABLE RISK LEVEL. THE CONMED SINGULAR AND CONMED OPTIMIZER POLYPECTOMY SNARES ARE SINGLE PATIENT USE, ONE PIECE, DISPOSABLE DEVICES CONSISTING OF A PROXIMAL HANDLE, OUTER SHEATH, INTERNAL DRIVE WIRE, AND DISTAL WIRE LOOP. ALL PARTS OF THIS DEVICE THAT EXIT THE DISTAL END OF THE ENDOSCOPE ARE CONSIDERED APPLIED PARTS. TO REDUCE THE RISK OF BREAKAGE AND INJURY TO THE PATIENT, THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS AND WARNINGS: - THIS DEVICE IS INTENDED FOR SINGLE PATIENT USE ONLY. THE PRODUCT AND THE PACKAGING HAVE NOT BEEN DESIGNED OR TESTED FOR REUSE. THE ABILITY TO EFFECTIVELY CLEAN AND RE-STERILIZE THIS SINGLE USE DEVICE AND SUBSEQUENT REUSE MAY ADVERSELY AFFECT THE CLINICAL PERFORMANCE, SAFETY AND/OR STERILITY OF THE DEVICE. - INSPECT THE SNARE DEVICE FOR KINKS, FRAYING WIRE OR ANY OTHER DAMAGE THAT MAY HAVE OCCURRED DURING TRANSIT. OPEN AND CLOSE THE SNARE LOOP TO CONFIRM SMOOTH MOVEMENT. DO NOT USE IF SNARE DEVICE IS DAMAGED. - DO NOT PRETEST THE SNARE WITH ELECTROCAUTERY OUTSIDE OF THE PATIENT. THIS COULD CAUSE OVERHEATING OF THE SNARE AND CAUSE IT TO FRAY OR BREAK DURING THE PROCEDURE RESULTING IN A POTENTIAL BURN TO THE PATIENT. - TO HELP PREVENT INADVERTENT INJURY OR PERFORATION OF INTERNAL ORGANS AND BODY STRUCTURE, POLYPECTOMY SHOULD ALWAYS BE PERFORMED UNDER DIRECT ENDOSCOPIC VISION. - THE ELECTROSURGICAL GENERATOR SHOULD BE PLACED ON THE OFF POSITION PRIOR TO ADVANCING OR REMOVING THE SNARE THROUGH THE ENDOSCOPE TO AVOID INJURY TO THE PATIENT OR EQUIPMENT THAT RESULTS FROM IMPROPER ELECTRICAL GROUNDING. ENSURE THAT THE PATIENT IS GROUNDED PRIOR TO USE OF THE MONOPOLAR ELECTROSURGICAL GENERATOR AND POLYPECTOMY SNARE TO AVOID PATIENT INJURY. - SNARES SHOULD ONLY BE USED BY OR UNDER THE SUPERVISION OF PHYSICIANS THOROUGHLY TRAINED IN ENDOSCOPIC POLYPECTOMY AND ELECTROSURGICAL GENERATOR SET-UP AND OPERATION. SNARES REQUIRE AN ENDOSCOPE WITH A MINIMUM WORKING CHANNEL OF 2.8 MM.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING A ERCP USING A 000476 SNARE OVAL, THE LOOP BROKE OFF INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH FORCEPS. AS REPORTED, THE PROCEDURE WAS OTHERWISE COMPLETED WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454084 OPTIMIZER POLYPECTOMY SNARE POLYPECTOMY SNARE FDI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 201508284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other