BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8709840 · Received June 18, 2019

    Report

    Report Number
    2210968-2019-82889
    Event Type
    Injury
    Date Received
    June 18, 2019
    Report Date
    May 23, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE) USED IN THIS PROCEDURE? CITATION: SURGERY TODAY (2018); 48:680¿686. DOI: HTTPS://DOI.ORG/10.1007/S00595-018-1647-6. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: APPLICATION OF A COMMERCIAL SINGLE-PORT DEVICE FOR ROBOTIC SINGLE INCISION DISTAL PANCREATECTOMY: INITIAL EXPERIENCE¿. AUTHORS: CHENG MING PENG, HSIN CHENG LIU, CHING LUNG HSIEH, YAO KUN YANG, TENG CHIEH CHENG, RUEY HWANG CHOU, YI JUI LIU. CITATION: SURGERY TODAY (2018); 48:680¿686. DOI: HTTPS://DOI.ORG/10.1007/S00595-018-1647-6. THE AUTHORS DESCRIBE HOW THEY APPLIED THE COMMERCIAL SINGLE PORT WITH MODIFICATION TO MAKE ROBOTIC SINGLE INCISION DISTAL PANCREATECTOMY FEASIBLE AND SAFE. BETWEEN JULY 1, 2015 AND DECEMBER 31, 2016, 10 PATIENTS (3 MALE AND 7 FEMALE; AGE RANGE: 36¿67 YEARS) UNDERWENT ROBOTIC-ASSISTED SINGLE-INCISION DISTAL PANCREATECTOMY FOR BENIGN OR MALIGNANT TUMORS. THE PANCREATIC AND SPLENIC VESSELS ARE ABLE TO BE HUNG UP AFTER COMPLETE DISSECTION. THEY WERE THEN TRANSECTED WITH ECHELON 60 SURGICAL STAPLER (ETHICON). THE STAPLER LINE IS REINFORCED WITH 3¿0 PROLENE SUTURES (ETHICON) FOR HEMOSTASIS AND TO PREVENT PANCREATIC LEAKAGE. REPORTED COMPLICATIONS INCLUDED: PATIENT 1, A (B)(6) MALE PATIENT WITH SPLENIC FOSSA HEMATOMA CAUSING LEFT UPPER ABDOMINAL DULL PAIN WHICH WAS TREATED EFFECTIVELY WITH PERCUTANEOUS DRAINAGE AND THE PATIENT WAS DISCHARGED. PATIENT 3, A (B)(6) FEMALE PATIENT WITH PANCREATIC LEAKAGE IN WHICH THE PATIENT TOLERATED ORAL INTAKE WELL AFTER CONSERVATIVE TREATMENT. THE DRAINAGE TUBE WAS REMOVED ABOUT 2 WEEKS POSTOPERATIVELY. PATIENT 10, A (B)(6) FEMALE PATIENT WITH BLOOD LOSS (250 ML) AND PANCREATIC LEAKAGE IN WHICH THE PATIENT TOLERATED ORAL INTAKE WELL AFTER CONSERVATIVE TREATMENT. THE DRAINAGE TUBE WAS REMOVED ABOUT 2 WEEKS POSTOPERATIVELY. IN CONCLUSION, THE RESULTS DEMONSTRATE THE SAFETY AND EFFICIENCY OF ROBOTIC SINGLE-INCISION DISTAL PANCREATECTOMY VIA THE MODIFIED PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501352 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention