BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 10277396 · Received July 15, 2020

    Report

    Report Number
    3005075853-2020-03576
    Event Type
    Injury
    Date Received
    July 15, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013211
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE UNK. BATCH # UNK. SEE JOURNAL ARTICLE. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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. DOES THE SURGEON/AUTHOR BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: RANDOMIZED CLINICAL TRIAL OF INTRACORPOREAL VERSUS EXTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC RIGHT COLECTOMY (IEA TRIAL) AUTHORS: J. BOLLO, V. TURRADO, A. RABAL1, E. CARRILLO, I. GICH, M. C. MARTINEZ, P. HERNANDEZ AND E TARGARONA CITATION: BJS 2020; 107: 364¿372. DOI: 10.1002/BJS.11389. THE AIM OF THIS RCT WAS TO COMPARE THE TWO SURGICAL TECHNIQUES, AND TO DEFINE THE POSSIBLE BENEFITS OF IA VERSUS EA IN PATIENTS UNDERGOING ELECTIVE RIGHT COLECTOMY. THIS RANDOMIZED, SINGLE-BLIND AND SINGLE-CENTRE CLINICAL TRIAL, THE INTRACORPOREAL VERSUS EXTRACORPOREAL ANASTOMOSIS (IEA) STUDY INVOLVES 139 PATIENTS WHO WERE REFERRED FOR TREATMENT OF A RIGHT COLONIC ADENOCARCINOMA FROM MAY 2015 TO JUNE 2018. SIXTY-NINE PATIENTS (34 MALE AND 35 FEMALE; MEAN AGE (SD): 72.7 (10.4) YEARS; AGE RANGE: 45-89 YEARS; BMI: 27.4(5.4) KG/M2) WERE INCLUDED IN THE INTRACORPOREAL ANASTOMOSIS GROUP, AND 70 PATIENTS (39 MALE AND 31 FEMALE; MEAN AGE (SD): 70.9(11.7) YEARS; AGE RANGE: 28-90 YEARS; BMI: 26.3 (4.7) KG/M2) WERE INCLUDED IN THE EXTRACORPOREAL ANASTOMOSIS GROUP. DURING THE PROCEDURE, THE FIRST TROCAR, ENDOPATH® XCEL¿ WITH OPTIVIEW¿ (ETHICON, TAMPA, FLORIDA, USA), WAS INSERTED IN THE LEFT ILIAC FOSSA TO CREATE THE PNEUMOPERITONEUM, AND AN EXPLORATORY LAPAROSCOPY UNDERTAKEN. A SECOND TROCAR WAS PLACED AT THE RIGHT ILIAC FOSSA AND ANOTHER IN THE SUPRAPUBIC REGION TO ACT AS WORKING PORTS. A FOURTH TROCAR WAS POSITIONED IN THE LEFT SUBCOSTAL FLANK FOR ASSISTANCE. IF INTRACORPOREAL ANASTOMOSIS (IA) WAS DESIGNATED, DISSECTION OF THE MESOCOLON WAS COMPLETED, AND THE ILEUM AND TRANSVERSE COLON WERE TRANSECTED USING AN ENDO-GIA STAPLER (ECHELON FLEX¿, 60 MM, BLUE CARTRIDGE; ETHICON). A SIDE-TO-SIDE ANTIPERISTALTIC ILEOCOLIC ANASTOMOSIS WAS CREATED WITH THE ENDO-GIA STAPLER (ECHELON FLEX¿, 60 MM, BLUE CARTRIDGE; ETHICON) AND THE ENTEROTOMY WAS CLOSED WITH TWO RUNNING SUTURES OF PROLENE® 2/0 (ETHICON). IF EXTRACORPOREAL ANASTOMOSIS (EA) WAS DESIGNATED, A TRANSVERSE INCISION WAS MADE. THE ILEUM AND COLON WERE EXTRACTED, AND DISSECTION OF THE MESOCOLON COMPLETED. A SIDE-TO-SIDE ANTIPERISTALTIC ANASTOMOSIS WAS CREATED WITH A GIA STAPLER (PROXIMATE®75 MM, BLUE CARTRIDGE; ETHICON) AND THE TWO BOWEL ENDS WERE CLOSED WITH A TA STAPLER (PROXIMATE® TX 90 MM; ETHICON). REPORTED COMPLICATIONS IN INTRACORPOREAL ANASTOMOSIS GROUP INCLUDED MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.73(2.32) AT DAY 1 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 1.81(1.85) AT DAY 2 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.06(2.19) AT DAY 3 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 1.72(1.91) AT DAY 4 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 1.71(2.18) AT DAY 5 (N-?), MEAN (SD) DECREASE IN HAEMOGLOBIN LEVEL OF 8.8 (1.7) (N-?) IN WHICH 5 PATIENTS HAD A RED BLOOD CELL TRANSFUSION, GRADE I PARALYTIC ILEUS (N-4), GRADE I WOUND SEROMA (N-3), GRADE II PARALYTIC ILEUS (N-5) AND PARENTERAL NUTRITION, ANAEMIA (N-3) IN WHICH THE PATIENT HAD A RBC TRANSFUSION, GRADE II LOWER GASTROINTESTINAL BLEEDING (N-2) WITH RBC TRANSFUSION, GRADE II WOUND INFECTION (N-3), GRADE II ANASTOMOTIC LEAK (N-3) IN WHICH 2 WERE TREATED WITH ANTIBIOTIC TREATMENT AND 1 WITH SURGICAL REOPERATION. IN EXTRACORPOREAL ANASTOMOSIS GROUP INCLUDED MEAN (SD) POSTOPERATIVE PAIN SCORE OF 3.01(2.29) AT DAY 1 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.91(2.25) AT DAY 2 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.36(2.12) AT DAY 3 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.49(2.23) AT DAY 4 (N-?), MEAN (SD) POSTOPERATIVE PAIN SCORE OF 2.42(1.93) AT DAY 5 (N-?), MEAN (SD) DECREASE IN HAEMOGLOBIN LEVEL OF 17.1 (1.7) (N-?) IN WHICH 9 PATIENTS HAD A RED BLOOD CELL TRANSFUSION, GRADE I PARALYTIC ILEUS (N-10), GRADE I WOUND SEROMA (N-3), LOWER GASTROINTESTINAL BLEEDING (N-1) IN WHICH THE PATIENT HAD A REOPERATION, GRADE I LOWER GASTROINTESTINAL BLEEDING (N-6), GRADE II PARALYTIC ILEUS (N-11) AND PARENTERAL NUTRITION, ANAEMIA (N-5) IN WHICH THE PATIENT HAD A RBC TRANSFUSION, GRADE II LOWER GASTROINTESTINAL BLEEDING (N-3) IN WHICH THE PATIENT HAD A RBC TRANSFUSION, GRADE II WOUND INFECTION (N-3), GARDE II COLITIS (N-1), GRADE II ANASTOMOTIC LEAK (N-5) IN WHICH 3 WERE TREATED WITH ANTIBIOTIC TREATMENT, 1 WITH RADIOLOGICAL DRAINAGE AND 1 WITH SURGICAL REOPERATION, ILEAL ISCHAEMIA (N-1) IN WHICH THE PATIENT HAD A REOPERATION, AND INTRA-ABDOMINAL HAEMATOMA (N-1) IN WHICH THE PATIENT HAD A REOPERATION. IN CONCLUSION, DURATION OF HOSPITAL STAY WAS SIMILAR, BUT IA WAS ASSOCIATED WITH LESS PAIN AND FEWER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742521 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. TLC75 10705036013211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention