BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 22363752 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04866
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    October 28, 2019
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). B3: UNKNOWN; CAPTURED AS AWARENESS DATE. DATE SENT: 6/30/2025. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: FOR THE HARMONIC DEVICE THE ARTICLE SAYS ¿BLEEDING¿ WAS THE PROCEDURE A LAPAROSCOPIC PROCEDURE AND NEEDED TO BE CONVERTED TO OPEN? DID THE PATIENT NEED TO HAVE A BLOOD TRANSFUSION? WERE YOU ABLE TO CONTROL THE BLEEDING? HOW WERE YOU ABLE TO CONTROL THE BLEEDING? WHAT IS THE CURRENT STATUS OF THE PATIENT? DID THE PATIENT NEED ANY DIFFERENT TYPE OF POST OP CARE DUE TO THE BLEEDING/OOZING? 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: SURGICAL CURE FOR EARLY RECTAL CARCINOMA AND LARGE ADENOMA: TRANSANAL ENDOSCOPIC MICROSURGERY (USING ULTRASOUND OR ELECTROSURGERY) COMPARED TO CONVENTIONAL LOCAL AND RADICAL RESECTION AUTHORS: C. LANGER, T. LIERSCH, M. SUSS, A. SIEMER, P. MARKUS, B. M. GHADIMI, L. FUZESI H. BECKER CITATION: INT J COLORECTAL DIS (2003); 18:222¿229. DOI: 10.1007/S00384-002-0441-4. THE PURPOSE OF THIS STUDY WAS TO EVALUATE EXPERIENCES WITH LARGE ADENOMAS AND EARLY RECTAL CARCINOMAS AT A SINGLE TERTIARY CARE CENTER. SPECIFICALLY, THIS STUDY COMPARED OUTCOME OF FOUR DIFFERENT SURGICAL TECHNIQUES. THIS RETROSPECTIVE STUDY INVOLVES 182 OPERATIONS PERFORMED BETWEEN 1990 AND 2001 ON 162 PATIENTS WITH EARLY RECTAL CARCINOMA (PT1, G1/2) OR ADENOMA TO COMPARE THE OUTCOME FOLLOWING FOUR DIFFERENT KINDS OF SURGICAL RESECTION TECHNIQUES; RS GROUP:27 (SEX RATIO: M/F 1.3; AGE: 67.3±12.7 YEARS) ANTERIOR OR ABDOMINOPERINEAL RESECTION WAS PERFORMED; TP GROUP, 76 (SEX RATIO: M/F 0.6; AGE: 64.7±17.1 YEARS) CONVENTIONAL TRANSANAL RESECTION USING PARK¿S RETRACTOR WAS PERFORMED, TEM-ES GROUP, 45 (SEX RATIO: M/F 1.7; AGE: 66.6±10.5 YEARS) TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) WITH ELECTROSURGERY WAS PERFORMED; AND TEM-UC GROUP, 34 (SEX RATIO: M/F 0.9; AGE: 62.1±11.1 YEARS) TRANSANAL ENDOSCOPIC MICROSURGERY WITH ULTRACISION (ETHICON) WAS PERFORMED. DURING THE RADICAL SURGERY FOR THE RS GROUP, THE STRAIGHT END-TO-END ANASTOMOSIS IN THE DOUBLE-STAPLING TECHNIQUE WAS SUTURED USING A CURVED CIRCULAR STAPLER (ETHICON). FOR THE TEM-UC GROUP, THE LAST 34 TEM OPERATIONS (JULY 1999 TO DECEMBER 2001) WERE PERFORMED EXCLUSIVELY WITH ULTRACISION (ETHICON). BY PULSING A PIEZOELECTRIC CRYSTAL WITH AN ELECTRICAL CURRENT, UC CONVERTS ELECTRICAL ENERGY INTO MECHANICAL ENERGY, VIBRATING THE BLADE OF THE INSTRUMENT WITH A CONSTANT FREQUENCY OF 55.5 KHZ. UC DISSECTS, COAGULATES, AND CUTS TISSUE WITHOUT VISIBILITY BEING IMPAIRED BY SMOKE. IN CASES OF PERFORATION OF THE PERITONEUM OR OF CLOSING THE RECTAL WALL DEFECT CONTINUOUSLY, ABSORBABLE SUTURES AND SILVER CLIPS (3-0 PDS, ETHICON) WERE USED. REPORTED COMPLICATION IN THE RS GROUP INCLUDED LEAKAGE (N-1) IN WHICH THE PATIENT UNDERWENT OPERATIVE REVISION. THIS PATIENT DIED OF A GENERAL SEPSIS AFTER THE ANASTOMOTIC LEAKAGE FOLLOWING A LOW ANTERIOR RESECTION. REPORTED COMPLICATION IN THE TEM-ES GROUP INCLUDED BLEEDING (N-?). REPORTED COMPLICATION IN THE TEM-UC GROUP INCLUDED LEAKAGE (N-1) AND BLEEDING (N-1). IN CONCLUSION, TEM USING UC SEEMS TO BE THE TECHNIQUE OF CHOICE. TP LEADS TO AN UNACCEPTABLE RECURRENCE RATE, AND RS RESULTS IN A HIGHER INCIDENCE OF COMPLICATION AND IMPAIRMENT OF LIFE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069569 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) HARMONIC SCALPEL CURVED SHEAR GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention