BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER MULTIVAC 50 ICW

    MDR report key: 12317988 · Received August 13, 2021

    Report

    Report Number
    3006524618-2021-00830
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 26, 2021
    Report Date
    October 20, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470003550
    PMA / PMN Number
    K033584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION IN H6: HEALTH IMPACT AND COMPONENT CODES UPDATED.4MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A CLINICAL REVIEW STATES PER THE COMPLAINT DETAILS, THE BROKEN PIECE WAS RETRIEVED FROM INSIDE OF THE PATIENT WITH TWEEZERS. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE WITH A SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. SINCE THERE WERE NO PATIENT INJURIES REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLIANT WOULD BE RE-ASSESSED. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE WANDS PACKAGING CONFIRMING PART NUMBER ASC4830-01 AND LOT NUMBER 2060983. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) HITTING THE DEVICE TIP AGAINST A HARD SURFACE. (2) USING THE DEVICE AS A LEVER TO ENLARGE SURGICAL SITE. (3) MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A CLINICAL REVIEW STATES PER THE COMPLAINT DETAILS, THE BROKEN PIECE WAS RETRIEVED FROM INSIDE OF THE PATIENT WITH TWEEZERS. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE WITH A SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. SINCE THERE WERE NO PATIENT INJURIES REPORTED, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLIANT WOULD BE RE-ASSESSED. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE WANDS PACKAGING CONFIRMING PART NUMBER ASC4830-01 AND LOT NUMBER 2060983. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHOULDER CLEAN THE ELECTRODE OF THE SUPER MULTIVAC 50 ICW WAND FELL OFF. THE BROKEN PIECE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217525 SUPER MULTIVAC 50 ICW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASC4830-01 2060983 00817470003550

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention