BEUDAMED
    FDA Adverse Event Summary report: N

    POLYPECTOMY SNARE SMALL OVAL

    MDR report key: 2494638 · Received March 16, 2012

    Report

    Report Number
    3007305485-2012-00018
    Date Received
    March 16, 2012
    Report Date
    April 27, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K820430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS A CONMED POLYPECTOMY SNARE, A SINGLE USE, ONE PIECE, DISPOSABLE DEVICE CONSISTING OF A PROXIMAL HANDLE, OUTER SHEATH, INTERNAL DRIVE WIRE, AND DISTAL WIRE LOOP. THE CONMED POLYPECTOMY SNARE IS INDICATED FOR ENDOSCOPIC RESECTION OF A POLYPOID LESION AND MAY BE USED IN CONJUNCTION WITH AN ELECTROSURGICAL GENERATOR. THESE SNARES ARE ALSO INDICATED TO BE USED WITHOUT ELECTROCAUTERY TO AID IN GRASPING A PLACEMENT GUIDEWIRE OR TETHER DURING PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) OR JEJUNAL FEEDING TUBE PLACEMENT. DHR / LHR, DEVICE HISTORY RECORD / LOT HISTORY RECORD, REVIEW WAS NOT COMPLETED BECAUSE THE LOT NUMBER OF THE ACTUAL DEVICE UTILIZED IN THE PROCEDURE WAS NOT AVAILABLE. THE DEVICE IN THIS INCIDENT WAS UTILIZED IN A COLONOSCOPY WHERE THE PATIENT HAD A TRANSVERSE POLYP, AND TWO RECTAL POLYPS REMOVED VIA HOT SNARE (IN CONJUNCTION WITH ELECTROCAUTERY). THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION OF THE DEVICE COULD NOT BE ASSESSED (I.E., ANY DEVICE DAMAGE, MALFUNCTION OR DEFECTS), AND, CONFIRMATION OF DEFECT OR CONFIRMATION OF CONMED PRODUCT COULD NOT BE ACCOMPLISHED. THE END-USER FACILITY PROVIDED STOCK SAMPLES FROM THE TWO LOTS IN THEIR PRESENT INVENTORY. ALTHOUGH THESE LOT SAMPLES ARE NOT KNOWN AS BEING REPRESENTATIVE SAMPLES OF THE ACTUAL DEVICE LOT, EACH OF THE TWO PROVIDED LOTS WERE VISUAL EXAMINED AND PLACED THROUGH ELECTRICAL CONTINUITY TESTING. PROPER SNARE LOOP MOVEMENT, ACTUATION AND RETRACTION, WAS OBSERVED IN ALL OF THE SAMPLES VISUALLY EXAMINED. FURTHERMORE, ELECTRICAL CONTINUITY TESTING BETWEEN THE ELECTRODE PROBE AND THE SNARE LOOP WAS TESTED FOR THE CHOSEN SAMPLES. NO CONTINUITY ISSUES WERE NOTED IN ANY OF THE TESTED SAMPLES. NO OBVIOUS MANUFACTURING DEFECTS WERE NOTED IN ANY OF THE RETURNED SAMPLES. THE EVENT DESCRIPTION YIELDS TOWARDS A CAUSE RESULTING FROM USER-ERROR DUE TO UNFAMILIARITY WITH THE DEVICE. THE REPORTER STATED IN THE COMPLAINT, "...THE DOCTOR DIDN'T LIKE THE DESIGN OF THEM AND FOUND THEM DIFFICULT TO OPERATE BECAUSE THEY WERE DIFFERENT THAN WHAT HE WAS USED TO...SHE BELIEVES THAT THE BLEEDINGS MAY BE THE RESULTS OF A USER-RELATED ISSUE, BUT WOULD STILL LIKE TO HAVE THEM LOOKED INTO." THE CUSTOMER COMPLAINT FAILURE MODE OF "BLEEDING FOLLOWING PROCEDURES" IS AN INHERENT RISK OF THE PROCEDURE ITSELF. IT IS WARNED IN THE IFU, INFORMATION FOR USE, THAT, "ADVERSE REACTIONS ASSOCIATED WITH THE USE OF POLYPECTOMY SNARES INCLUDE ACUTE AND DELAYED HEMORRHAGE, BOWEL PERFORATION, EXPLOSION OF INTRALUMINAL GASES, LOCALIZED OR SYSTEMIC INFECTIONS, COAGULATION SYNDROME, AND OTHER RISKS ASSOCIATED WITH THE METHODS AND MEDICATIONS UTILIZED IN SURGICAL PROCEDURES." NO ROOT CAUSE CAN BE DETERMINED WITHOUT EXAMINATION OF THE ACTUAL DEVICE UTILIZED IN THE PROCEDURE. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED NOR CONFIRMED ANY MANUFACTURING DEFECTS ASSOCIATED WITH THE RETURNED DEVICES. NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THE FOLLOWING MEDWATCHES ARE ASSOCIATED WITH EACH OTHER: 3007305485-2012-00017 AND 3007305485-2012-00018.

    Additional Manufacturer Narrative · 1

    THE SNARES UTILIZED IN THE DESCRIBED PROCEDURES WERE DISCARDED BY THE END-USER FACILITY. LOT SAMPLES HAVE BEEN RETURNED TO CONMED CORPORATION FOR EVALUATION. WHEN THE QUALITY ENGINEERING EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. THE FOLLOWING MEDWATCHES ARE ASSOCIATED: 3007305485-2012-00017, AND, 3007305485-2012-00018.

    Description of Event or Problem · 1

    IT WAS REPORTED, "...THAT THE DOCTOR DIDN'T LIKE THE DESIGN OF THEM AND FOUND THEM DIFFICULT TO OPERATE BECAUSE THEY WERE DIFFERENT THAN WHAT HE WAS USED TO. SHE ALSO STATED THAT THERE WERE TWO INCIDENTS WHICH RESULTS IN PATIENTS BLEEDING FOLLOWING PROCEDURES. SHE IS UNSURE, BUT BELIEVES THAT THE LOT USED ON THE PATIENTS WAS 1112124; THE DEVICES WERE THROWN AWAY. SHE BELIEVES THAT THE BLEEDINGS MAY BE THE RESULTS OF A USER-RELATED ISSUE, BUT WOULD STILL LIKE TO HAVE THEM LOOKED INTO. SHE IS RETURNING HER ENTIRE STOCK, WHICH INCLUDES AN ADDITIONAL LOT (1201094)." THERE WAS NO FURTHER REPORT ON THE OUTCOME OF THE PATIENTS. NO REPORT OF INCREASED HOSPITALIZATION AND NO REPORT OF RETURN TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYPECTOMY SNARE SMALL OVAL POLYECTOMY SNARE FDI CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other