BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAMANTYS BIPOLAR SEALER 6.0

    MDR report key: 5001506 · Received August 13, 2015

    Report

    Report Number
    1226420-2015-00128
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 15, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: AQM 6.0 BIPOLAR SEALER PRODUCT NUMBER: 23-112-1, LOT NUMBER: PHC255D0, EXPIRATION DATE: 2020-03-23 QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: -RECEIVED IN A (B)(4) SHIPPING ENVELOPE WITHOUT ANY PACKAGING TO FILL THE NEGATIVE SPACE -DEVICE WAS IN A HEAT SEAL VIEW-PACK, NOT SEALED, NO BIO-HAZARD BAGS WERE USED AND NO ORIGINAL PACKAGING WAS INCLUDED -DEVICE CANNOT BE CONFIRMED WITH THE INFORMATION IN THE GCH; NOR CAN THE DEVICE THAT WAS SENT BACK BE CONFIRMED AS THE REPORTED COMPLAINT DEVICE. NO ADDITIONAL PAPERWORK WAS INCLUDED DEVICE VISUAL INSPECTION: DEVICE IS CLEAN AND DOES NOT APPEAR USED -THE ELECTRICAL CABLE WITH THE PLUG END AND SALINE TUBING HAVE BEEN OFF THE DEVICE AND WERE NOT INCLUDED IN THE RETURN (FIGURE 1) -THERE ARE NO VISUAL SIGNS RELATED TO THE DESCRIPTION -THE BLUE BUTTON HAS A TACTILE FEEL FUNCTIONAL INSPECTION: NOT ABLE TO PERFORM FUNCTIONAL INSPECTION DUE TO THE ELECTRICAL CABLE WITH THE PLUG END AND SALINE TUBING BEING CUT OFF LHR REVIEW: A REVIEW OF THE LHR FOR LOT # PHC255D0 REVEALED: 25-1426-01 REV. L ¿ CABLE ASSY, 3-COND, AQM 6.0 - SCRAPPED QTY. 1 ¿ SWITCH FAILURE INVESTIGATION CONCLUSION: COMPLAINT NOT CONFIRMED DUE TO THE ELECTRICAL CABLE WITH THE PLUG END AND SALINE TUBING BEING CUT OFF PREVENTING FUNCTIONAL TESTING OF THE DEVICE WHICH IMPEDES THE INVESTIGATION. NO CONCLUSIONS COULD BE MADE ON THE CAUSE OF THE FAILURE BECAUSE THE FAILURE COULD NOT BE REPRODUCED. THE IFU LISTS PROPER USE, PRECAUTIONS, AND WARNINGS WHEN UTILIZING THE DEVICE AS OUTLINED AND SPECIFICALLY AS LISTED BELOW. THE COMPLAINT WILL BE TRACKED AND TRENDED IN GCH. PRECAUTIONS SURGERY SHOULD BE PERFORMED BY PERSONS WITH ADEQUATE TRAINING AND PREPARATION. PERSONNEL SHOULD FULLY UNDERSTAND THE NATURE AND USE OF RF BEFORE PERFORMING ELECTROSURGICAL PROCEDURES TO AVOID THE RISKS OF SHOCK AND BURN HAZARDS TO BOTH THE PATIENT AND THE OPERATOR AND DAMAGE TO THE INSTRUMENTATION. SETTING UP THE AQUAMANTYS DISPOSABLE BIPOLAR DEVICE WARNINGS: ELECTRIC SHOCK HAZARD. ENSURE THAT THE DEVICE PLUG IS CORRECTLY CONNECTED AND THAT NO METAL PINS ARE EXPOSED. ACTIVATING THE AQUAMANTYS DISPOSABLE BIPOLAR DEVICE WARNINGS: DO NOT ACTIVATE THE AQUAMANTYS DISPOSABLE BIPOLAR DEVICE WHEN THE ELECTRODES ARE NOT IN CONTACT WITH THE TISSUE TO BE TREATED. ACTIVATING THE DEVICE WHEN NOT IN CONTACT WITH TISSUE MAY RESULT IN INADVERTENT TISSUE DAMAGE OR USER INJURY DUE TO CONTACT WITH HOT SALINE. DO NOT WRAP ELECTRICAL CABLE OF DEVICE AROUND METAL OBJECTS. THIS MAY INDUCE CURRENTS THAT COULD LEAD TO SHOCKS, FIRES, OR INJURIES TO THE PATIENT OR SURGICAL TEAM. INSPECT THE DEVICE AND CORD FOR BREAKS, CRACKS, NICKS, OR OTHER DAMAGE BEFORE USE. FAILURE TO OBSERVE THIS CAUTION MAY RESULT IN INJURY OR ELECTRICAL SHOCK TO THE PATIENT OR SURGICAL TEAM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    NEAR THE START OF THE CASE, WHEN THE SURGEON WAS ACTIVATING THE HANDPIECE, HE FELT A SLIGHT SHOCK FROM THE BUTTON THROUGH HIS INDEX FINGER. THE DEVICE WAS NOT TOUCHING THE PATIENT AT THE TIME AND THERE WAS NO IMPACT TO THE PATIENT AT ALL. THE CASE WAS COMPLETED WITH AN ALTERNATIVE MEDICAL DEVICE. SURGEON DID NOT REQUIRE TREATMENT OR MEDICAL INTERVENTION. BIOMED DEPARTMENT WITHIN THE FACILITY TESTED GENERATOR AND IT PASSED ALL TESTING PERFORMED.

    Description of Event or Problem · 1

    NEAR THE START OF THE CASE, WHEN THE SURGEON WAS ACTIVATING THE HANDPIECE, HE FELT A SLIGHT SHOCK FROM THE BUTTON THROUGH HIS INDEX FINGER. THE DEVICE WAS NOT TOUCHING THE PATIENT AT THE TIME AND THERE WAS NO IMPACT TO THE PATIENT AT ALL. THE CASE WAS COMPLETED WITH AN ALTERNATIVE MEDICAL DEVICE. SURGEON DID NOT REQUIRE TREATMENT OR MEDICAL INTERVENTION. BIOMED DEPARTMENT WITHIN THE FACILITY TESTED GENERATOR AND IT PASSED ALL TESTING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536035 AQUAMANTYS BIPOLAR SEALER 6.0 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 23-112-1 PHC255D0

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR