BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR S90 4.0MM W/INTEGR HDP -EA

    MDR report key: 8951097 · Received August 30, 2019

    Report

    Report Number
    1221934-2019-58165
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    July 18, 2019
    Report Date
    August 2, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009398
    PMA / PMN Number
    K122425
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H3, H6: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. THERE WERE NO ANOMALIES OBSERVED ON THE CONNECTOR, CORD, HANDLE OR SHAFT. VISUAL OBSERVATION OF THE ELECTRODE REVEALS THE DISTAL TIP SHOWS SIGNS OF ACTIVATION. THERE IS TISSUE DEBRIS AROUND THE TIP AND SALINE SOLUTION STAINS ON THE DEVICE¿S SURFACE AND IN THE SUCTION TUBE. UNDER MAGNIFICATION, IT WAS OBSERVED THAT THE MANIFOLD SHOWS SIGNS OF MELTING BETWEEN 4 - 7 O'CLOCK POSITIONS OF THE TIP. THIS DAMAGE TO THE TIP WOULD LEAD TO THE BREAKAGE AT THE ACTIVE TIP, CONFIRMING THIS COMPLAINT. THIS DEVICE WAS NOT TESTED FOR SAFETY REASONS. THE IFU STATES: ¿OBSERVE EXTREME CAUTION WHEN USING ELECTRO SURGERY IN CLOSE PROXIMITY TO OR IN DIRECT CONTACT WITH ANY METAL OBJECTS. THE MAJORITY OF ARTHROSCOPES AND ARTHROSCOPIC INSTRUMENTS ARE METAL. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE.¿ NO FURTHER INFORMATION WAS PROVIDED TO DETERMINE IF THE ABOVE-MENTIONED FACTORS CONTRIBUTED TO THIS FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED ON (B)(6) 2019 FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SINCE THE FUNCTION OF THE ELECTRODE IS TO ABLATE TISSUE, THE RISK ASSOCIATED WITH SPARKING OF THE ELECTRODE TIP WITHIN THE JOINT SPACE IS LOW. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING A ROTATOR CUFF PLASTY PROCEDURE THE CERAMIC OF THE VAPR S90 IS BROKEN. THE GENERATOR SHOWS ALERT CODE, REMOVED THE DEVICE, NOTED THE CERAMIC PART WAS BROKEN, THE BROKEN PIECE COULD NOT BE FOUND, MAYBE REMAINED IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE PATIENT IS STABLE NOW. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE BREAKAGE DID NOT RESULT IN A SURGICAL DELAY GREATER THAN 30 MINUTES, THERE WERE NO ANATOMICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE DEVICE BREAKAGE, AND SURGICAL INTERVENTION IS NOT PLANNED FOR A LATER DATE. THE AFFILIATE ALSO REPORTED THE SURGEON ATTEMPTED TO LOCATED THE BROKEN PIECES BUT WAS UNSUCCESSFUL. IT WAS REPORTED THE PIECES MAYBE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744783 VAPR S90 4.0MM W/INTEGR HDP -EA ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1808073 10886705009398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention