BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9413486 · Received December 4, 2019

    Report

    Report Number
    3005075853-2019-23974
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS NO CONTACT INFORMATION WAS PROVIDED, THE FOLLOWING QUESTIONS WAS NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2019. 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 : LAPAROSCOPIC CYSTOGASTROSTOMY : EXPERIENCE OF 134 CASES. AUTHOR : VIRINDER KUMAR BANSAL, OM PRAKASH, ASURI KRISHNA, SUBODH KUMAR, SHARDOOL V GUPTA, ADITYA BAKSI, M. C. MISRA, PRAMOD GARG. CITATION: SURG ENDOSC (2019) 33:S153. THE AIM OF THIS RETROSPECTIVE STUDY IS TO PRESENT THE EXPERIENCE OF LAPAROSCOPIC CYSTOGASTROSTOMY AT A TERTIARY REFERRAL CENTRE. BETWEEN JULY 2005 AND JULY 2008, A TOTAL OF 134 PATIENTS WITH PSEUDOCYST OF PANCREAS OPERATED IN A SINGLE SURGICAL UNIT. OUT OF 134 PATIENTS, 129 PATIENTS UNDERWENT LAPAROSCOPIC CYSTOGASTROSTOMY AND 5 PATIENTS LAPAROSCOPIC LOOP CYSTOJEJUNOSTOMY. UNDER GENERAL ANAESTHESIA, ANTERIOR WALL OF STOMACH WAS OPENED AROUND 3¿4 CM WITH HARMONIC SCALPEL (ETHICON). COMPLAINT INCLUDED INTRAOPERATIVE BLEEDING (N=3). IN 2 PATIENTS OPEN RE-EXPLORATION WAS DONE FOR POST-OPERATIVE UPPER GASTROINTESTINAL BLEED. THE DATA IN THIS STUDY SHOWED THAT LAPAROSCOPIC CYSTOGASTROSTOMY GIVES EXCELLENT RESULT WITH A VERY HIGH CYST RESOLUTION AND MINIMAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207059 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE