BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9485138 · Received December 17, 2019

    Report

    Report Number
    3005075853-2019-24472
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    January 1, 2014
    Report Date
    November 21, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/17/2019. DATE OF EVENT: PUBLICATION YEAR OF 2014. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: TRANSVAGINAL SPECIMEN EXTRACTION VERSUS CONVENTIONAL MINILAPAROTOMY AFTER LAPAROSCOPIC ANTERIOR RESECTION FOR COLORECTAL CANCER: MID-TERM RESULTS OF A CASE-MATCHED STUDY. AUTHOR/S: HYE JIN KIM, GYU-SEOG CHOI, JUN SEOK PARK, SOO YEUN PARK, JONG PIL RYUK, SUNG HWAN YOON. CITATION: SURG ENDOSC (2014) 28:2342¿2348; DOI 10.1007/S00464-014-3466-1. THIS PROSPECTIVELY COLLECTED DATABASE STUDY AIMED TO DESCRIBE THE SURGICAL TECHNIQUE FOR TOTALLY LAPAROSCOPIC ANTERIOR RESECTION WITH TRANSVAGINAL SPECIMEN EXTRACTION (TVSE) IN FEMALE PATIENTS WITH LEFT-SIDED COLORECTAL CANCER AND TO COMPARE THE CLINICAL OUTCOMES IN PATIENTS WITH TVSE WITH A CASE-MATCHED GROUP OF PATIENTS UNDERGOING CONVENTIONAL LAPAROSCOPIC ANTERIOR RESECTION WITH MINILAPAROTOMY (LAP) BASED ON A LARGE. FROM OCT2006 TO JUL2011, 58 FEMALE PATIENTS UNDERWENT TVSE FOR LEFT-SIDE COLORECTAL CANCER. THESE PATIENTS WERE CASE-MATCHED WITH 59 PATIENTS WHO UNDERWENT CONVENTIONAL LAP. IN TVSE GROUP, RECTAL TRANSECTION WAS ACHIEVED WITH 60-MM ENDOSCOPIC LINEAR STAPLER. AFTER RESECTION OF THE RECTUM, THE PROXIMAL COLON WAS DIVIDED INTRACORPOREALLY. A PLASTIC BAG (LAP BAG; SEJONG MEDICAL, (B)(4)) WAS INSERTED THROUGH THE VAGINAL PORT, AND THE SPECIMEN WAS PLACED INSIDE THE BAG. NEXT, THE VAGINAL COLPOTOMY WAS ENLARGED TO 3¿4 CM IN LENGTH USING ULTRASONIC SHEARS (HARMONIC SCALPEL; ETHICON ENDO-SURGERY INC., (B)(4), USA) FROM THE ABDOMINAL SIDE. INTRAOPERATIVE MORBIDITY INCLUDED BLEEDING (N=?). POSTOPERATIVE COMPLICATION INCLUDED BLEEDING (N=1) WHICH REQUIRED TRANSFUSION, AND VAGINAL SPOTTING AFTER SURGERY (N=1) WHICH RESOLVED AFTER 1 MONTH WITHOUT TREATMENT. IN THIS STUDY, AFTER 3-MONTH FOLLOW-UP VISITS, THE PATIENTS DID NOT COMPLAIN OF COLPOTOMY-RELATED SYMPTOMS, EXCEPT FOR ONE PATIENT WHO HAD VAGINAL SPOTTING FOR 1 MONTH. THE TVSE GROUP EXPERIENCED SUPERIOR POSTOPERATIVE OUTCOMES WITH EARLIER RETURN OF BOWEL FUNCTION, DECREASED PAIN, AND FEWER WOUND COMPLICATIONS, ALTHOUGH THE MEAN OPERATIVE TIME WAS LONGER RELATIVE TO THAT IN THE LAP GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277001 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1