BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPRO-CLIP

    MDR report key: 38393 · Received September 18, 1996

    Report

    Report Number
    1210157-1996-00001
    Event Type
    Injury
    Date Received
    September 18, 1996
    Report Date
    August 19, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    DSS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT #Z96-321. NO SAMPLES WERE RETURNED FOR EVALUATION. CLIPS FROM THE COMPLAINT LOT WERE EVALUATED FOR LIGATING EFFICACY IN A CANINE MODEL. RESULTS INDICATE THAT HEMOSTASIS WAS OBTAINED INTRAOPERATIVELY AND AT SEVEN DAYS POST-OPERATIVELY. IN AN EARLIER STUDY USING A PORCINE MODEL THE CLIPS WERE USED TO LIGATE THE CYSTIC DUCT AND ARTERY. POST MORTEM EVALUATION OF THE LIGATED SITES INDICATED THE CYSTIC DUCT HAD MACROSCOPIC EVIDENCE OF HEALING AT SEVEN DAYS. THERE WAS NO EVIDENCE OF NECROSIS AT ANY SITE. A REVIEW OF THE LOT HISTORY WAS UNREMARKABLE AND THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS LOT. ON THE BASIS OF THE TEST RESULTS AND INVESTIGATION, THE CLIPS SHOULD HAVE PERFORMED SATISFACTORILY UNDER NORMAL CONDITIONS OF USE. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUR INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. COMPLAINT #Z96-321. INITIAL REPORT IDENTIFIED "PRODUCT PROBLEM"; HOWEVER, CO IS UNABLE TO DETERMINE IF THE REPORTED EVENT WAS DUE TO A PRODUCT PROBLEM OR SOME OTHER EVENT. THEREFORE, CO IS REPORTING AS AN "ADVERSE EVENT". SECTION F-10 WAS ALSO CHANGED FROM DEVICE CODE 1379 = FAILURE TO MAINTAIN, TO 2204 = UNK. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFO NOT YET VERIFIED BY SHERWOOD DAVIS AND GECK TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY SHERWOOD DAVIS AND GECK THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR A SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED FOR LIGATION OF THE CYSTIC DUCT. POSTOPERATIVELY THE PT DEVELOPED BILE LEAKAGE AND A COLLECTION OF BILE OCCURRED IN THE LIVER BED. THE BILE WAS ASPIRATED ENDOSCOPICALLY AND THE PT HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPRO-CLIP Implant ABSORBABLE LIGATING CLIP DSS SHERWOOD DAVIS AND GECK NA 895276

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention