BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2210968-2018-75108

    MDR report key: 7777252 · Received August 13, 2018

    Report

    Report Number
    2210968-2018-75108
    Event Type
    Injury
    Date Received
    August 13, 2018
    Report Date
    July 23, 2018
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 NUMBER HAS NOT BEEN PROVIDED. CITATION: SURG ENDOSC (2013) 27:S214¿S215, FP07. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : TOTALLY LAPAROSCOPIC PANCREATICODUODENECTOMY: A SINGLE INSTITUTIONAL EXPERIENCE. AUTHOR: S SAHAY, O DAMRAH, S RAHMAN. CITATION: SURG ENDOSC (2013) 27:S214¿S215, FP07. THE STUDY AIMED TO DETERMINE THE SAFETY AND EFFICACY OF TOTALLY LAPAROSCOPIC PANCREATICODUODENECTOMY PARTICULARLY WITH REFERENCE TO A MODIFIED ¿¿DUNKING TECHNIQUE¿¿ USING INTERRUPTED SUTURE. IN THIS STUDY, 10 PATIENTS (MEDIAN AGE OF 70 YEARS [RANGED 54-80 YEARS]) WITH MALIGNANCIES (MODERATELY DIFFERENTIATED AMPULLARY ADENOCARCINOMAS [N=2], AMPULLARY ADENOMAS [N=2], PANCREATIC ADENOCARCINOMAS [N=2] AND INTRADUCTAL PAPILLARY MUCINOUS NEOPLASMS [N=4]) UNDERWENT TOTALLY LAPAROSCOPIC PANCREATICODUODENECTOMY. PANCREATICODUODENECTOMY WAS PERFORMED IN STANDARD FASHION WITH A SINGLE LOOP RECONSTRUCTION WITH INTRACORPOREAL ANASTAMOSIS OF P-J AND H-J. G-J ANASTAMOSES WAS ANTECOLIC STAPLED THE P-J ANASTAMOSIS WAS FASHIONED USING A ¿¿DUNKING¿¿ TECHNIQUE WITH INTERRUPTED 3/0 ETHIBOND SUTURES. IN THE STUDY, THERE WAS A SINGLE BILE LEAK NOTED WHICH WAS TREATED WITH PTC, AND G-J BLEED WHICH WAS MANAGED ENDOSCOPICALLY. THE EARLY EXPERIENCE SUGGESTS TOTAL LAPAROSCOPIC PANCREATICODUODENECTOMY CAN BE UNDERTAKEN SAFELY AND HAS VERY FAVOURABLE POST-OPERATIVE RESULTS IN WELL SELECTED PATIENTS. CAUTION NEEDS TO BE EXERCISED IN PATIENTS WITH A NONSTENTED NON-DILATED EXTRA-HEPATIC BILIARY TREE.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STAPLER