BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIENT SUPER MULTIVAC 50 IFS

    MDR report key: 9918948 · Received April 2, 2020

    Report

    Report Number
    3006524618-2020-00142
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    March 2, 2020
    Report Date
    June 27, 2025
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006551
    PMA / PMN Number
    K180848
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE AMBIENT SUPER MULTIVAC 50 IFS DEVICE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, "A PART OF ACTIVE ELECTRODE BROKE AND THE BROKEN PIECE FELL OFF INSIDE THE PATIENT. THE PIECE COULD NOT BE RETRIEVED. THE EVENT HAPPENED DURING SURGERY." THE RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2032705 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. NO FURTHER INVESTIGATION OR ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. REVIEW OF THE PRODUCT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO PREVENT DAMAGE TO THE DEVICE DURING USE. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. ALTHOUGH THE CYTOTOXICITY REPORT ALL OF THE MATERIALS ARE BIO-COMPATIBLE, THIS IS FOR SHORT TERM USE. LONG TERM IMPLANTATION DATA IS NOT AVAILABLE. THE PATIENT IMPACT BEYOND POSSIBLE MICRO-MOTION AND/OR MIGRATION, LOCAL IRRITATION/DISCOMFORT, AND PROBABLE MRI RESTRICTIONS CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A PICTURE OF THE DEVICE HAS BEEN SENT. PER THE CUSTOMER PHOTO, ELECTRODES SHOW EXTENSIVE EROSION AND IT IS PARTIALLY DETACHED WITH JAGGED EDGES ON THE REMAINING ELECTRODE LEGS. VISUAL INSPECTION UNDER MAGNIFICATION OF THE WAND SHOWS MODERATE ELECTRODE/ SCREEN EROSION WITH CONTAMINATION/DISCOLORATION AND SCRATCH/SCUFF MARKS ON THE SPACER AND RETURN ELECTRODE. HOWEVER A PIECE OF THE SCREEN IS BROKEN OFF, IT WASN´T SENT WITH THE DEVICE. NO MANUFACTURING ABNORMALITIES WERE IDENTIFIED. PRIOR TO ACTIVATION THE WAND R2 RESISTANCE WAS MEASURED WITH 1619 OHMS. AFTER BYPASSING THE ERROR E-7 THE DEVICE PRODUCED PLASMA ON ABLATE/COAG MIN./MAX. SETTINGS ON THE REMAINING PARTS OF THE SCREEN; THE SUCTION LINE PERFORMED AS INTENDED. THE COMPLAINT WAS CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: THE DEVICE POTENTIALLY COMING INTO CONTACT WITH A METAL OBJECT SUCH AS A CANNULA. MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE OR USING THE DEVICE AS A LEVER TO ENLARGE A SURGICAL SITE OR GAIN ACCESS TO TISSUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THE RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2032705 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. NO FURTHER INVESTIGATION OR ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. REVIEW OF THE PRODUCT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS TO PREVENT DAMAGE TO THE DEVICE DURING USE. CLINICAL EVALUATION WAS COMPLETED AND CONCLUDED THAT BASED ON THE LIMITED INFORMATION PROVIDED THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. ALTHOUGH THE CYTOTOXICITY REPORT ALL OF THE MATERIALS ARE BIO-COMPATIBLE, (PN 44981 REV. A) THIS IS FOR SHORT TERM USE. LONG TERM IMPLANTATION DATA IS NOT AVAILABLE. THE PATIENT IMPACT BEYOND POSSIBLE MICRO-MOTION AND/OR MIGRATION, LOCAL IRRITATION/DISCOMFORT, AND PROBABLE MRI RESTRICTIONS CANNOT BE DETERMINED. NO FURTHER MEDICAL ASSESSMENT CAN BE RENDERED AT THIS TIME. A PICTURE OF THE DEVICE HAS BEEN SENT. PER THE CUSTOMER PHOTO, ELECTRODES SHOW EXTENSIVE EROSION AND IT IS PARTIALLY DETACHED WITH JAGGED EDGES ON THE REMAINING ELECTRODE LEGS. A FUNCTIONAL EVALUATION CANNOT BE PERFORMED. THE WAS CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: THE DEVICE POTENTIALLY COMING INTO CONTACT WITH A METAL OBJECT SUCH AS A CANNULA. MECHANICAL DISPLACEMENT OF TISSUE THROUGH APPLIED FORCE OR USING THE DEVICE AS A LEVER TO ENLARGE A SURGICAL SITE OR GAIN ACCESS TO TISSUE. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PART OF ACTIVE ELECTRODE BROKE AND THE BROKEN PIECE FELL OFF INSIDE THE PATIENT. THE PIECE COULD NOT BE RETRIEVED. THE EVENT HAPPENED DURING SURGERY, A BACKUP DEVICE WAS AVAILABLE. AFTER SURGERY IN (B)(6) 2020, THE PATIENT SUBSEQUENTLY DEVELOPED ATOPIC DERMATITIS, WHICH CLAIMED WAS AFFECTED BY THE REMAINING TIP ELECTRODE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PART OF THE ACTIVE ELECTRODE BROKE AND THE BROKEN PIECE FELL OFF INSIDE THE PATIENT. THE PIECE COULD NOT BE RETRIEVED. THE EVENT HAPPENED DURING SURGERY, A BACKUP DEVICE WAS AVAILABLE. NO PATIENT HARM WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381035 AMBIENT SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4830-01 2032705 00817470006551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other