BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7658685 · Received July 3, 2018

    Report

    Report Number
    2210968-2018-74027
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. PLEASE ADVISE IF THE ¿OTHER¿ EVENTS MENTIONED IN THE ARTICLE ARE RELATED TO THE ETHICON PRODUCT INVOLVED. IF SO, PLEASE SPECIFY THE EVENTS WITH CORRESPONDING NUMBER OF PATIENTS. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH. 2016; 26: E95¿E99 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MODIFIED HAND-SEWN CLOSURE WITH RETROPERITONEAL TISSUE-COVERING METHOD PREVENTS PANCREATIC FISTULA IN LAPAROSCOPIC DISTAL PANCREATECTOMY"AUTHORS: WENBIN JI, PHD, YOULONG WANG, MM, LIE WANG, MD, HUAMIN TAN, MD, JINGWANG TAN, PHDCITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH. 2016; 26: E95¿E99 THE AIM OF THIS STUDY WAS TO COMPARE COMPLICATIONS ASSOCIATED WITH DISTAL PANCREATECTOMY (DP), ESPECIALLY REGARDING THE FORMATION OF PANCREATIC FISTULA, WITH PARTICULAR ATTENTION TO THE STAPLER AND HANDSEWN CLOSURE TECHNIQUE. BETWEEN JANUARY 2004 AND JUNE 2012, A TOTAL OF 47 PATIENTS UNDERWENT LAPAROSCOPIC DISTAL PANCREATECTOMY (LDP). THESE PATIENT¿S PANCREATIC BODIES WERE SIMILAR, AND THEY WERE SUBJECTED TO CLOSURE OF THE PANCREATIC STUMP EITHER BY STAPLER (STAPLE GROUP, N=21; 13 MALE AND 8 FEMALE PATIENTS; AGE RANGE: 34 TO 59 YEARS OLD; BMI: 29.4) OR BY A MODIFIED HAND-SEWN TECHNIQUE (SEWN GROUP, N=26 17 MALE AND 9 FEMALE PATIENTS; AGE RANGE: 52 TO 68 YEARS OLD; BMI: 32.1), AND WERE SUBSEQUENTLY RETROSPECTIVELY REVIEWED. DURING THE PROCEDURE IN THE SEWN GROUP, A RUNNING SUTURE WAS USED FOR THE RETROPETROLEUM AND VENTRAL PANCREATIC CAPSULA TO REINFORCE THE FIRST-LAYER CLOSURE LINE, IN WHICH PANCREATIC PARENCHYMA MAYBE INJURED, USING MONOFILAMENT, NON-ABSORBABLE PROLENE 4-0 SUTURES WAS PERFORMED. IN THE SEWN GROUP, REPORTED COMPLICATIONS INCLUDED GRADE B PANCREATIC FISTULA (N-1) AND PANCREATITIS OF THE REMNANT (N-1). IT WAS CONCLUDED THAT THE PRESENT STUDY SHOWED THAT MODIFIED HAND-SUTURING SEEMS TO BE THE PREFERRED CLOSURE TECHNIQUE FOR THE PANCREATIC REMNANT, A PROSPECTIVE STUDY IS WORTH TESTING IT, AND MAY BE DEFINED AS THE ¿GOLD STANDARD¿ FOR PANCREATIC REMNANT AWAY FROM SUPERIOR MESENTERIC VEIN AGAINST WHICH THE SAFETY OF ANY NEW TECHNIQUE WOULD HAVE TO BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500665 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention