BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VAPR ELECTRODE

    MDR report key: 9186092 · Received October 14, 2019

    Report

    Report Number
    1221934-2019-58923
    Event Type
    Injury
    Date Received
    October 14, 2019
    Report Date
    October 8, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: OFER LEVY, ET AL, 2008 ¿ARTHROSCOPIC CAPSULAR RELEASE FOR POSTTRAUMATIC SHOULDER STIFFNESS¿, JOURNAL OF SHOULDER AND ELBOW SURGERY, VOL 17, NO.3: PP 410-414 (UNITED KINGDOM). THE PURPOSE OF THIS STUDY WAS TO REPORT THE RESULTS OF ARTHROSCOPIC CAPSULAR RELEASE FOR THESE POSTTRAUMATIC STIFF SHOULDERS, USING A RADIOFREQUENCY PROBE. BETWEEN JANUARY 1996 AND MAY 2002, 21 PATIENTS WITH POSTTRAUMATIC STIFFNESS OF THE SHOULDER WERE EVALUATED AT THE READING SHOULDER UNIT. DIABETIC PATIENTS WERE EXCLUDED, AND NO PATIENT PRESENTED WITH DEGENERATIVE ARTHRITIS. AT PRESENTATION, 11 PATIENTS (52.4%) COMPLAINED OF PAIN AND STIFFNESS, AND THE REMAINING 10 HAD STIFFNESS WITHOUT PAIN. THE STUDY DESCRIBES THE FOLLOWING PROCEDURE: THE ARTHROSCOPIC RELEASE WAS DONE UNDER GENERAL ANESTHESIA, COMBINED WITH A REGIONAL BLOCK (INTERSCALENE OR INFRACLAVICULAR BLOCK) IN ALL PATIENTS. THEY WERE PLACED IN THE LATERAL POSITION. A 4.5-MM ARTHROSCOPE WAS PLACED INTO THE GLENOHUMERAL JOINT THROUGH A POSTERIOR PORTAL, AND AN ANTERIOR PORTAL WAS ESTABLISHED. AN ABLATIVE RADIOFREQUENCY PROBE (ANGLED END EFFECT PROBE, DEPUY MITEK, WARSAW, IN) WAS USED TO PERFORM A CIRCUMFERENTIAL RELEASE OF THE CAPSULE, STARTING IN THE ROTATOR INTERVAL, WORKING INFERIORITY, AND AROUND THE GLENOID. THE DEVICE INVOLVED: RADIOFREQUENCY PROBE (ANGLED END EFFECT PROBE, DEPUY MITEK, WARSAW, IN). COMPLICATIONS MENTIONED IN THE STUDY: ONE PERIOPERATIVE COMPLICATION, WHICH INVOLVED A PERIPROSTHETIC FRACTURE AT THE TIP OF A STEMMED PROSTHESIS, OCCURRED DURING THE INITIAL MOBILIZATION AFTER SURGERY OWING TO SEVERE, PREEXISTING DISUSE OSTEOPOROSIS. ONE PATIENT DETERIORATED IN THE LONG-TERM FOLLOW-UP DESPITE ARTHROSCOPIC RELEASE. SHE HAD PRESENTED WITH A MALUNITED FRACTURE OF THE SURGICAL NECK OF THE HUMERUS THAT HAD BEEN TREATED NONOPERATIVELY. AVASCULAR NECROSIS OF THE HUMERAL HEAD LATER DEVELOPED FROM THE ORIGINAL INJURY, AND SHE UNDERWENT RESURFACING ARTHROPLASTY OF THE SHOULDER. THE UNSATISFIED PATIENT HAD DEVELOPED AVASCULAR NECROSIS AFTER A SURGICAL NECK FRACTURE, AS MENTIONED. NONE OF THE PATIENTS WITH ISOLATED PREOPERATIVE STIFFNESS DEVELOPED LONG-TERM POSTOPERATIVE PAIN. OF THE 10 PATIENTS WHO HAD PAIN PREOPERATIVELY, 4 HAD PAIN AT 6 MONTHS BUT ONLY 2 HAD PAIN AT 33 MONTHS. FROM THE REVIEW OF THE ARTICLE IT CAN BE CONCLUDED THAT ARTHROSCOPIC CAPSULAR RELEASE IS A USEFUL TREATMENT FOR RESISTANT POSTTRAUMATIC STIFF SHOULDER, PARTICULARLY TO ALLEVIATE OF PAIN AND RESTORE A FUNCTIONAL ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980268 UNKNOWN VAPR ELECTRODE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention