BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_ENSEAL X1 TISSUE SEALER CURVED JAW

    MDR report key: 22530102 · Received July 17, 2025

    Report

    Report Number
    3005075853-2025-05627
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K172580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/17/2025. D4 BATCH#: UNKNOWN. B3: UNKNOWN: CAPTURED AS AWARENESS DATE. D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: EVALUATION OF PERFORMANCE AND SAFETY OUTCOMES OF ENSEAL® TISSUE SEALERS. PERIOPERATIVE BLEEDING: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR PERIOPERATIVE BLEEDING (SEE APPENDIX 1) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: GENERAL SURGERY; G2 ARTICULATING: 15, X1 CURVED AND STRAIGHT: 36, X1 LARGE: 86. PERIOPERATIVE BLEEDING: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR PERIOPERATIVE BLEEDING (SEE APPENDIX 1) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: GYNECOLOGIC SURGERY; G2 ARTICULATING: 2, X1 CURVED AND STRAIGHT: 7, X1 LARGE JAW: 10. PERIOPERATIVE BLEEDING: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR PERIOPERATIVE BLEEDING (SEE APPENDIX 1) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: THORACIC SURGERY; G2 ARTICULATING: 1, X1 CURVED AND STRAIGHT: 1, X1 LARGE: 1. PERIOPERATIVE BLEEDING: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR PERIOPERATIVE BLEEDING (SEE APPENDIX 1) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: UROLOGIC SURGERY; X1 LARGE: 1. THERMAL INJURY: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR THERMAL INJURY (SEE APPENDIX 2) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: GYNECOLOGIC SURGERY, X1 LARGE: 1. SOFT TISSUE INJURY: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR SOFT TISSUE INJURY (SEE APPENDIX 3) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: GENERAL SURGERY; G2 ARTICULATING: 19, X1 CURVED AND STRAIGHT: 56, X1 LARGE: 177. SOFT TISSUE INJURY: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR SOFT TISSUE INJURY (SEE APPENDIX 3) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: GYNECOLOGIC SURGERY; G2 ARTICULATING: 1, X1 CURVED AND STRAIGHT: 35, X1 LARGE: 7. SOFT TISSUE INJURY: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR SOFT TISSUE INJURY (SEE APPENDIX 3) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: THORACIC SURGERY; X1 LARGE: 1. SOFT TISSUE INJURY: DEFINED AS THE PRESENCE OF AN ICD-10-CM DIAGNOSIS CODE FOR SOFT TISSUE INJURY (SEE APPENDIX 3) AS A PRIMARY OR SECONDARY DIAGNOSIS DURING THE INDEX EPISODE OF CARE WHERE A STUDY DEVICE WAS USED: UROLOGIC SURGERY; X1 CURVED AND STRAIGHT: 4. THIS IS FOR ETHICON. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807634 UNK_ENSEAL X1 TISSUE SEALER CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GENERATOR.