BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VAPR ELECTRODE

    MDR report key: 9239971 · Received October 25, 2019

    Report

    Report Number
    1221934-2019-59229
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    October 21, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. - (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VENTURA, A., ET AL (2013), TREATMENT OF POST-TRAUMATIC OSTEOCHONDRAL LESIONS OF THE TALUS: A FOUR-STEP APPROACH, KNEE SURGERY SPORTS TRAUMATOLOGY ARTHROSCOPY, VOL. 21(6), PAGES 1245-1250 (ITALY). DOI: 10.1007/S00167-012-2028-0 THE STUDY EMPHASIZES ON EVALUATING THE OUTCOMES OF PATIENTS WITH SPORTS-RELATED OSTEOCHONDRAL LESIONS (OCLS) OF THE TALUS. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: THIRTY-EIGHT PATIENTS (23 MALE AND 15 FEMALE) WITH AT LEAST ONE MRI-DOCUMENTED OCL OF THE ANKLE WERE TREATED FROM 2004 TO 2010. FOURTEEN PATIENTS PRACTICED CONTACT SPORTS BEFORE INJURY (MARTIAL ARTS, RUGBY, SOCCER, BASKETBALL, ETC.) AND 24 NON-CONTACT SPORTS (VOLLEYBALL, RUNNING, TENNIS, ETC.). TWELVE PRACTICES SPORT AT A COMPETITIVE LEVEL, FIVE OF THEM AS PROFESSIONALS AND THE OTHER 26 PRACTICED SPORT AT THE RECREATIONAL LEVEL. MEDIAN AGE AT SURGERY WAS 39 YEARS (RANGE 18-52). MEAN LESION SIZE WAS 1.0CM2. ALL PATIENTS UNDERWENT A FOUR-STEP SURGICAL PROCEDURE INCLUDING SYNOVECTOMY, DEBRIDEMENT AND MICROFRACTURES OF THE OCL, CAPSULAR SHRINKAGE, AND BRACING AND NON-WEIGHTBEARING FOR 21 DAYS. IMMEDIATELY AFTER THE OPERATION, AN ANKLE BRACE WAS APPLIED. FOR THE FIRST THREE WEEKS, PATIENTS WERE INSTRUCTED TO WALK WITH NON-WEIGHTBEARING WITH THE USE OF 2 CRUTCHES. AFTER THE REMOVAL OF THE BRACE, PATIENTS WERE ENCOURAGED TO REGAIN WEIGHTBEARING AS TOLERATED AND WERE INSTRUCTED TO PERFORM PROPRIOCEPTIVE AND COMPLETE ANKLE RANGE OF MOTION (ROM) EXERCISES. RETURN TO SPORTS WAS PERMITTED 12 WEEKS POST-OPERATIVELY. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL PATIENTS UNDERWENT A FOUR-STEP SURGICAL PROCEDURE INCLUDING SYNOVECTOMY, DEBRIDEMENT AND MICROFRACTURES OF THE OCL, CAPSULAR SHRINKAGE, AND BRACING AND NON-WEIGHTBEARING FOR 21 DAYS. THE DEVICES INVOLVED WERE: VAPR T SIDE EFFECT THERMAL ELECTRODE (MITEK, WESTWOOD, MA, USA) WITH A 3.5MM TIP, AND MOTORIZED 4.0MM SHAVER. COMPLICATIONS MENTIONED IN THE ARTICLE: - 1 PATIENT HAD FURTHER MALLEOLAR FRACTURE ON THE OPERATED ANKLE. - 1 PATIENT EXPERIENCED 5° DORSIFLEXION LIMITATION. - 1 PATIENT HAD 10° LESS COMPARED TO THE CONTRALATERAL SIDE. - 2 PATIENTS COMPLAINED OF PERMANENT ALTERED SENSATION OF THE ANTEROLATERAL ASPECT OF THE FOOT. - IN 2 ANKLES, VISIBLE DEFECT WAS STILL PRESENT TOGETHER WITH SUBCHONDRAL ABNORMALITIES. A COPY OF THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033424 UNKNOWN VAPR ELECTRODE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention