BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMIZER® POLYPECTOMY SNARE, SMALL (MINI) OVAL

    MDR report key: 5777262 · Received July 7, 2016

    Report

    Report Number
    3007305485-2016-00073
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    May 15, 2016
    Report Date
    June 9, 2016
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    FDI
    PMA / PMN Number
    K820430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USED/DAMAGED DEVICE WAS NOT RETURNED FOR EVALUATION DUE TO CONTAMINATION. HOWEVER, TWO (2) UNOPENED/UNUSED DEVICES FROM THE SAME LOT NUMBER WERE RETURNED TO CONMED ON 20-JUN-2016 FOR EVALUATION. AS OF THIS FILING, THE INVESTIGATION REMAINS IN PROCESS, A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE COMPLAINT INVESTIGATION. DEVICE WAS DISCARDED AT USER FACILITY.

    Additional Manufacturer Narrative · 1

    AS REPORTED, DUE TO CONTAMINATION, THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, TWO (2) 000476 OPTIMIZER SNARE LOT SAMPLES WERE RECEIVED FOR EVALUATION ON 20-JUN-2016, THE SAMPLES WERE EXAMINED AND FUNCTIONALLY TESTED IN THE LABORATORY. VISUAL INSPECTION NOTED NO VISIBLE DEFECTS OR DAMAGE ASSOCIATED WITH THE RETURNED PRODUCT. A FUNCTIONAL TEST WAS PERFORMED USING A STRAIN METER. ONE (1) SNARE DEVICE PASSED PULL TEST. THE OTHER DEVICE FAILED FOR LOOP STRENGTH. AN EXAMINATION OF THE LOOP CONNECTION FOUND ONE LEG OF THE LOOP DETACHED FROM THE CONNECTOR. AN EXAMINATION OF THE CONNECTOR SHOWED ONLY A SLIGHT DEFORMATION OF THE SWAGED HYPOTUBE/CONNECTOR. THIS LOT WAS MANUFACTURED 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. OF THE LOT CONTAINING (B)(4) UNITS, THERE WERE (B)(4) COMPLAINTS RECEIVED FOR DETACHMENT OF COMPONENTS. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY SHOWED A TOTAL OF (B)(4) COMPLAINTS WITH A TOTAL OF (B)(4) 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 (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 RESERIALIZE 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 CUSTOMER REPORTED THAT DURING USE OF THE OPTIMIZER POLYPECTOMY SNARE IN A POLYPECTOMY PROCEDURE, THE SNARE CAME APART. THE METAL FRAGMENT FROM THIS DEVICE WAS LEFT BEHIND IN THE PATIENT. THE FRAGMENT WAS GRABBED WITH BIOPSY FORCEPS AND RETRIEVED WITH NO PROBLEMS NOTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED. TO DATE, THERE HAS BEEN NO ADDITIONAL INFORMATION RECEIVED REGARDING THE PATIENT'S LATEST CONDITION OR ANY INDICATION THAT A LONG TERM ADVERSE EFFECT HAS OCCURRED. THIS REPORT IS RAISED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE.

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431119 OPTIMIZER® POLYPECTOMY SNARE, SMALL (MINI) OVAL POLYPECTOMY SNARE FDI CONSOLIDATED MEDICAL EQUIPMENT COMPANY 201508284

    Patients

    Seq Age Sex Outcome Treatment
    1 Other