BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER POLYPECTOMY SNARE, EXTRA SMALL, OVAL

    MDR report key: 5688481 · Received May 31, 2016

    Report

    Report Number
    3007305485-2016-00052
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Report Date
    June 21, 2016
    Manufacturer
    CONMED CORPORATION
    Product Code
    FDI
    UDI-DI
    00653405053425
    PMA / PMN Number
    K820430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICES TO CONMED CORPORATION FOR EVALUATION IS ANTICIPATED; HOWEVER, THEY HAVE NOT BEEN RECEIVED TO DATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE QUALITY ENGINEERING EVALUATION. NOT YET RETURNED TO CONMED CORPORATION.

    Additional Manufacturer Narrative · 1

    TWO USED/DAMAGED OPTIMIZER SNARES WERE RETURNED FOR EVALUATION. THE DEVICES WERE EXAMINED IN THE LABORATORY AND VISUAL INSPECTION NOTED BOTH DEVICES HAVE DETACHED LOOPS. THE LOOPS WERE EXAMINED AND FOUND TO HAVE LITTLE OR NO DEFORMATION INDICATING THERE WAS LITTLE FORCE IN DETACHING THE LOOPS FROM THE CRIMPED CONNECTOR. THE EVALUATION RESULTS FURTHER INDICATED THAT THE TYPICAL HOUR-GLASS SHAPE WAS NOT PRESENT GIVING AN INDICATION THAT THERE WAS INSUFFICIENT CRIMPING OF THE LOOP ASSEMBLY CONNECTOR. AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THIS PROBLEM. THIS LOT WAS MANUFACTURED ON 16-FEB-2016. 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 WAS NO OTHER SIMILAR COMPLAINT RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF (B)(4) COMPLAINTS (INCLUDING THIS ONE) WITH A TOTAL OF (B)(4) UNITS FOR LOOP DETACHMENT. DURING THIS SAME 2-YEAR TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE OCCURRENCE RATE FOR THIS REPORTED FAILURE MODE (B)(4) 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

    PER END-USER FACILITY, THE OPTIMIZER POLYPECTOMY SNARES BROKE OFF IN THE PATIENT'S COLON AND HAD TO BE RETRIEVED WITH FORCEPS. THIS OCCURRED THREE TIMES IN THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A FOURTH SNARE WITH NO FURTHER COMPLICATIONS, SURGICAL DELAY OR PATIENT INJURY. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EVENT HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344813 OPTIMIZER POLYPECTOMY SNARE, EXTRA SMALL, OVAL POLYPECTOMY SNARE FDI CONMED CORPORATION 201602164 00653405053425

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR