BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 9652575 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00634
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 SURGEON/AUTHOR 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

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: LAPAROSCOPIC DISTAL PANCREATECTOMY TO TREAT SOLID PSEUDOPAPILLARY TUMORS IN CHILDREN: TRANSITION FROM OPEN TO LAPAROSCOPIC APPROACHES IN SUITABLE CASES. AUTHOR/S: JUNG-MAN NAMGOONG, DAE-YEON KIM, SEONG-CHUL KIM, SONG-CHEOL KIM , JI-HEE HWANG, KI-BYUNG SONG. CITATION: PEDIATR SURG INT (2014) 30:259¿266; DOI: 10.1007/S00383-014-3471-4. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE OUTCOMES OF OPEN AND LAPAROSCOPIC DISTAL PANCREATECTOMY (LDP) IN THE TREATMENT OF SOLID PSEUDOPAPILLARY TUMORS (SPT) IN CHILDREN. FROM JANUARY 1995 TO DECEMBER 2012, 22 PATIENTS (FEMALE=17, MALE=5; MEAN AGE=15 YEARS, AGE RANGE=9 ¿ 18 YEARS) UNDERWENT DISTAL PANCREATECTOMY. THE PATIENTS WERE DIVIDED INTO TWO GROUPS, FOURTEEN UNDERWENT LDP AND THE REMAINING 8 UNDERWENT OPEN DISTAL PANCREATECTOMY (ODP). DURING THE PROCEDURE IN LDP, PANCREATIC DISSECTION WAS STARTED USING LAPAROSCOPIC INSTRUMENTS OR AN ULTRASONIC SHEARS (HARMONIC SCALPEL; ETHICON) BY MOBILIZING THE LOWER PANCREATIC MARGIN AND GAINING ACCESS TO THE POSTERIOR PANCREATIC SURFACE. THE PANCREAS WAS DIVIDED USING AN ENDOSCOPIC STAPLER (ECHELON 60; ETHICON). REPORTED COMPLICATION INCLUDED FLUID COLLECTION (N=1); CHYLOUS DRAIN (N=1); INTRAOPERATIVE BLOOD LOSS OF 165ML (RANGE 50-1040 ML) (N=?). IN CONCLUSION, LDP TREATMENT FOR SPT IN CHILDREN IS ASSOCIATED WITH A SHORTER HOSPITALIZATION AND A SHORTER TIME TO ORAL INTAKE COMPARED TO ODP. LDP IS A SAFE AND FEASIBLE OPTION FOR SPT IN SELECT PEDIATRIC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118344 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention