BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 10288437 · Received July 17, 2020

    Report

    Report Number
    3005075853-2020-03614
    Event Type
    Injury
    Date Received
    July 17, 2020
    Report Date
    June 19, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNKNOWN. ADDITIONAL INFORMATION RECEIVED: NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN'T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RISK AND EARLY PREDICTIVE FACTORS OF ANASTOMOTIC LEAKAGE IN LAPAROSCOPIC LOW ANTERIOR RESECTION FOR RECTAL CANCER . AUTHOR(S): MASAHIRO FUKADA, NOBUHISA MATSUHASHI, TAKAO TAKAHASHI, HISASHI IMAI, YOSHIHIRO TANAKA, KAZUYA YAMAGUCHI AND KAZUHIRO YOSHIDA. CITATION: FUKADA ET AL. WORLD JOURNAL OF SURGICAL ONCOLOGY (2019) 17:178 / HTTPS://DOI.ORG/10.1186/S12957-019-1716-3. THE PURPOSE OF THIS RETROSPECTIVE, SINGLE-INSTITUTION STUDY WAS TO IDENTIFY RISK AND EARLY PREDICTIVE FACTORS OF ANASTOMOTIC LEAKAGE (AL). BETWEEN FEB 2008 AND NOV 2017, A TOTAL OF 101 PATIENTS [N=53 MALE, N=48 FEMALE, MEDIAN AGE 64 YEARS (RANGE, 18¿83 YEARS), MEDIAN BMI 22 KG/M2 (RANGE, 15.4¿29.7 KG/M2)] WITH PRIMARY RECTAL CANCERS UNDERWENT LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) WITH DST ANASTOMOSIS. AFTER CLAMPING THE DISTAL SIDE OF THE TUMOR TO WASH OUT THE RECTUM, THE RECTUM WAS TRANSECTED USING A LINEAR STAPLE (ECHELON 60 OR POWERED ECHELON 60, GOLD CARTRIDGE, ETHICON ENDO-SURGERY). AFTER THE SURGICAL SPECIMEN WAS REMOVED THROUGH THE SMALL INCISION, THE ANVIL HEAD OF A CIRCULAR STAPLE WAS POSITIONED IN THE PROXIMAL COLON. THE CIRCULAR STAPLER (CDH, 25MM OR 29 MM, ETHICON) WAS INSERTED THROUGH THE RECTUM, AND DST ANASTOMOSIS WAS COMPLETED INTRACORPOREALLY. AIRTIGHTNESS WAS ROUTINELY TESTED BY TRANSANAL INSTILLATION OF AIR. IF THE LEAK TEST WAS POSITIVE, AN INTRACORPOREAL REINFORCEMENT SUTURE WITH 3¿0 VICRYL (ETHICON) WAS PLACED AT THE WEAK POINT. POSTOPERATIVE COMPLICATIONS INCLUDED SYMPTOMATIC ANASTOMOTIC LEAKAGE (N=13) WHEREIN 5 REQUIRED RE-OPERATION (STOMA CONSTRUCTION); 8 CASES OF AL THAT DID NOT REQUIRE RE-OPERATION AND WERE TREATED BY IRRIGATION AND DRAINAGE THROUGH THE PELVIC DRAIN. ANTIBIOTICS WERE ADMINISTERED IN ALL AL CASES UNTIL THE INFLAMMATORY RESPONSE WAS REDUCED OR THERE WERE NO SIGNS OF INFLAMMATION. FEVER (>= 38 °C) POD 1 (N=9); FEVER (>= 38 °C) POD 3 (N=7); TACHYCARDIA (>= 100 BPM) (N=4); TACHYCARDIA (>= 100 BPM) (N=1); WATERY STOOL (N=6). IN THIS STUDY, INTRAOPERATIVE BLOOD LOSS WAS AN INDICATOR OF DIFFICULTY IN A TRANSECTION AND ANASTOMOSING PROCEDURE, AND FEVER-POD3 AND EARLY FIRST DEFECATION DAY AFTER SURGERY WERE INDEPENDENT EARLY PREDICTIVE FACTORS FOR AL. CAREFUL SURGERY USING AN APPROPRIATE TECHNIQUE AND STANDARDIZED PROCEDURES WITH MINIMAL BLEEDING AND CAREFUL POSTOPERATIVE MANAGEMENT PAYING ATTENTION TO FEVER AND DEFECATION MAY PREVENT THE ONSET AND SEVERITY OF AL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756468 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention