BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8550131 · Received April 25, 2019

    Report

    Report Number
    2210968-2019-80706
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    March 28, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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: HONG KONG MED J. 2002; 8: 394-9. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC CHOLECYSTECTOMY VERSUS OPEN CHOLECYSTECTOMY IN ELDERLY PATIENTS WITH ACUTE CHOLECYSTITIS: RETROSPECTIVE STUDY" AUTHORS: CH CHAU, CN TANG, WT SIU, JPY HA, MKW LI CITATION: HONG KONG MED J. 2002; 8: 394-9. THE OBJECTIVES OF THIS RETROSPECTIVE STUDY WAS TO CHECK ON THE SAFETY AND EFFICACY OF LAPAROSCOPIC CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS IN ELDERLY PATIENTS BY COMPARING THE RESULTS WITH OPEN CHOLECYSTECTOMY. A TOTAL OF 31 PATIENTS (20 MALE AND 11 FEMALE PATIENTS) UNDERWENT LAPAROSCOPIC SURGERY AND 42 PATIENTS (22 MALE AND 20 FEMALE PATIENTS) UNDERWENT OPEN SURGERY (AGED 75 YEARS OR OLDER) CHOLECYSTECTOMY FOR ACUTE CHOLECYSTITIS BETWEEN JANUARY 1994 AND DECEMBER 1999 WERE SELECTED FROM THE DATABASE. IN THE LAPAROSCOPIC CHOLECYSTECTOMY (LC) GROUP, THE CYSTIC DUCT STUMP WAS MANAGED WITH A PDS ABSOLOK ABSORBABLE POLYDIOXANONE SELF-LOCKING CLIP (ETHICON). IN THE EARLY STUDY PERIOD, THE PRACTICE USED THE CATGUT LIGATION USING CATGUT PLAIN, ETHI-ENDO-NAHT, EH 7326 (ETHICON). IN THE OPEN CHOLECYSTECTOMY GROUP (OC), THE CYSTIC DUCT STUMP WAS LIGATED WITH VICRYL 2-0 ABSORBABLE SUTURES (ETHICON). IN THE LC GROUP, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1) AND CYSTIC STUMP LEAKAGE (N-2) IN WHICH ENDOPROSTHESIS PLACEMENT AND PERCUTANEOUS DRAINAGE OF ANY INTRA-ABDOMINAL COLLECTION IF A DRAIN HAS NOT BEEN INSERTED DURING SURGERY. IN THE OC GROUP, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-6) AND CYSTIC STUMP LEAKAGE (N-1) IN WHICH ENDOPROSTHESIS PLACEMENT AND PERCUTANEOUS DRAINAGE OF ANY INTRA-ABDOMINAL COLLECTION IF A DRAIN HAS NOT BEEN INSERTED DURING SURGERY. IN THE ERA OF LAPAROSCOPIC SURGERY, WITH INCREASING EXPERIENCE AND THE ADVENT OF NEW TECHNOLOGY, OLD AGE IS NO LONGER A CONTRAINDICATION FOR LC FOR ACUTE CHOLECYSTITIS. THIS STUDY DEMONSTRATES THAT THE LAPAROSCOPIC APPROACH IS MORE BENEFICIAL THAN THE OPEN SURGERY APPROACH IN TERMS OF SHORTER HOSPITAL STAY AND LOWER MORBIDITY RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345708 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention