BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION COAGULATOR

    MDR report key: 11209706 · Received January 21, 2021

    Report

    Report Number
    2242056-2021-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 21, 2020
    Report Date
    June 15, 2021
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    GEI
    UDI-DI
    10841291104926
    PMA / PMN Number
    K914193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT UNIT WAS RETURNED BY THE CUSTOMER AND WAS INVESTIGATED. VISUAL INSPECTION CONFIRMED THAT THE BELL TIP OF THE CANNULA HAD BROKEN OFF AS REPORTED BY THE COMPLAINANT. ENGINEERING EVALUATED THE DEVICE BY FIRST MEASURING IT AND COMPARING IT AGAINST THE SPECIFICATIONS FOR OUTER DIAMETER, INNER DIAMETER, AND WALL THICKNESS. IT WAS FOUND THAT THE COMPLAINT UNIT WAS MEASURED OUTSIDE OF SPECIFICATION FOR INNER DIAMETER, RESULTING IN A SLIGHTLY THICKER WALL. HOWEVER, IT IS POSSIBLE THAT THIS DIAMETER WAS IMPACTED BY THE BREAK AND DOES NOT NECESSARILY POINT TO A ROOT CAUSE FOR THE FAILURE. NEXT, VARIOUS PARTS IN PRODUCTION WERE INSPECTED THAT COULD HAVE INTRODUCED A FAILURE. 3 CANNULAS IN PRODUCTION THAT HAD TRIMMED INSULATION WERE INSPECTED AND THERE APPEARED TO BE A LIGHT CIRCULAR SCORE MARK IN THE CANNULA WHERE THE INSULATION HAD BEEN TRIMMED. 3 UNITS OF THE PLAIN BRASS CANNULA FROM RAW MATERIAL (PRIOR TO ANY PROCESSING) WERE ALSO INSPECTED AND NO SCORE MARK WAS OBSERVED. LASTLY, 2 UNITS OF A FINAL DEVICE, PART 050-005 LOT 119C, WERE INSPECTED TO CONFIRM THAT SCORING WAS PRESENT. TO DETERMINE IF SCORING COULD BE THE ROOT CAUSE OF THE FAILURE, 12 CANNULAS WERE BENT TO DETERMINE IF THE FAILURE OF THE TIP BREAKING OFF COULD BE REPLICATED. IT WAS FOUND THAT NONE OF THE CANNULAS BROKE WHEN BENT TO ~90°. ADDITIONALLY, WHEN BENT IN EXCESS OF 9 LBS., THE CANNULA TUBE BEGAN FLATTENING AND BENT TO ~180°. NO AMOUNT OF FORCE WAS ABLE TO RE-CREATE THE SHEAR SEEN IN THE COMPLAINT UNIT. THE SUPPLIER OF THE CANNULAS WAS CONTACTED ABOUT THIS INCIDENT, AND THE RETURNED UNIT WAS SENT TO THE SUPPLIER AFTER A&E'S INSPECTION. HOWEVER, THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION PERTAINING TO THE INVESTIGATION. IN CONCLUSION, A&E MEDICAL WAS NOT ABLE TO REPLICATE THE FAILURE OR DETERMINE THE ROOT CAUSE OF THE TIP BREAKING OFF. IT IS IMPORTANT TO NOTE THAT 29,890 SUCTION COAGULATORS WERE SOLD IN THE PAST 24 MONTHS FROM THE DATE THIS COMPLAINT WAS REPORTED (23DEC2018 TO 23DEC2020), RESULTING IN AN OCCURRENCE RATE OF 0.003%. ALSO, THERE HAVE BEEN NO OTHER ISSUES ON THIS PRODUCT LOT FROM OTHER CUSTOMERS. PRODUCTION HAS NOT REPORTED ANY IN-PROCESS ISSUES OR SEEN ANY CHANGES WITH MANUFACTURING. THEREFORE, GIVEN THE VERY LOW OCCURRENCE RATE AND THE INCONCLUSIVE RESULTS OF THE DEVICE EVALUATION, THIS EVENT APPEARS TO BE ISOLATED WITH AN UNDETERMINED ROOT CAUSE AT THIS POINT IN TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED, FURTHER INVESTIGATION WILL BE CONDUCTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE SUCTION COAGULATOR WAS READY TO BE USED BUT BEFORE THEY COULD USE IT, THE TIP BROKE OFF.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY FOR SUCTION COAGULATORS SHOWS THAT THERE HAVE BEEN NO PRIOR COMPLAINTS IN THE PAST 2 YEARS REGARDING THE TIP OF THE SUCTIONAL COAGULATOR BREAKING OFF. THIS RESULTS IN A COMPLAINT RATE OF (B)(4) (1 COMPLAINT PER (B)(4) SUCTION COAGULATORS SOLD IN THE PAST 24 MONTH PERIOD FROM THE DATE THIS COMPLAINT WAS REPORTED). THE RETURNED DEVICE WAS RECENTLY RECEIVED; VISUAL INSPECTION CONFIRMED THAT THE BELL TIP WAS BROKEN OFF FROM THE BODY OF THE CANNULA AS DESCRIBED BY THE CUSTOMER. FURTHER EVALUATION OF THE RETURNED DEVICE WILL BE CONDUCTED TO INVESTIGATE POTENTIAL ROOT CAUSE. A CLOSURE REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SUCTION COAGULATOR WAS READY TO BE USED BUT BEFORE THEY COULD USE IT, THE TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106217 SUCTION COAGULATOR SUCTION COAGULATOR GEI A&E MEDICAL CORPORATION 050-030 01740 10841291104926

    Patients

    Seq Age Sex Outcome Treatment
    1