BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREEN RELOAD FOR ECHELON 60

    MDR report key: 17950341 · Received October 17, 2023

    Report

    Report Number
    3005075853-2023-07540
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    January 6, 2023
    Report Date
    October 17, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001782
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/17/2023. D4: BATCH # UNK. 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. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 0

    TITLE: DOUBLE-STAPLED ANASTOMOSIS WITHOUT "DOG-EARS" REDUCES THE ANASTOMOTIC LEAKAGE IN LAPAROSCOPIC ANTERIOR RESECTION OF RECTAL CANCER: A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY. CITATION: FRONT. SURG. 9:1003854; DOI 10.3389/FSURG.2022.1003854. THE AIM OF THIS STUDY WAS TO INVESTIGATE WHETHER THE RESECTION OF "DOG-EARS" IN LAPAROSCOPIC ANTERIOR RESECTION OF RECTAL CANCER (CALLED MODIFIED DOUBLE-STAPLING TECHNIQUE, MDST) COULD REDUCE THE RATE OF ANASTOMOTIC LEAKAGE IN PATIENTS WITH MIDDLE AND HIGH RECTAL CANCER, AS COMPARED WITH THE CONVENTIONAL DOUBLE-STAPLING TECHNIQUE (DST). BETWEEN SEPTEMBER 2015 TO OCTOBER 2018, 232 PATIENTS WITH MIDDLE AND HIGH RECTAL CANCER WHO UNDERWENT LAPAROSCOPIC ANTERIOR RESECTION WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMLY DIVIDED INTO MDST GROUP (N = 116) AND DST GROUP (N = 116). THE MDST GROUP CONSISTED OF 70 MALES AND 46 FEMALES WITH A MEAN AGE OF 63.0 ± 8.5 YEARS AND A MEAN BMI OF 22.8 ± 2.9 KG/M2. THE DST GROUP CONSISTED OF 57 MALES AND 59 FEMALES WITH A MEAN AGE OF 61.3 ± 9.3 YEARS AND A MEAN BMI OF 22.5 ± 2.9 KG/M2. PATIENT PREPARATION AND THE DISSECTION METHOD BEFORE ANASTOMOSIS WERE NOT DIFFERENT BETWEEN THE MDST GROUP AND THE DST GROUP. THE TRANSECTION OF THE DISTAL RECTUM WAS PERFORMED USING 1 CARTRIDGE OF LAPAROSCOPIC LINEAR STAPLER (ECR60G, ETHICON ENDO-SURGERY INC.). THE CIRCULAR STAPLER DEVICE (CDH33, ETHICON ENDO-SURGERY INC.) WAS INSERTED THROUGH THE ANUS UP TO THE CLOSE RECTAL LUMEN AFTER THE REMOVAL OF THE ANVIL AND THE FORMATION OF THE STAPLE LINE FORMING THE DOG-EARS ON THE RECTAL STUMP. IN THE MDST GROUP, LAPAROSCOPIC SUTURE ON THE TWO DOG-EARS WAS PERFORMED USING A NON-ETHICON 3-0 MONOFILAMENT SUTURE (MANUFACTURER: UNKNOWN) AND THE DOG-EARS WERE REMOVED FROM THE STAPLE LINE AROUND THE TROCAR BY MEANS OF A SUTURE TIED THROUGH THEM. THEN A TRUE END-TO-END ANASTOMOSIS WAS PERFORMED AFTER STAPLER FIRING. - HOWEVER, THE SURGEON DID NOT MAKE A LAPAROSCOPIC SUTURE ON THE 2 DOG-EARS IN THE PATIENTS OF THE DST GROUP. AFTER ANASTOMOSIS, THE AIR LEAK TEST WAS PERFORMED IN THE PATIENTS OF BOTH GROUPS. A DRAIN WAS ROUTINELY PLACED IN THE PELVIC CAVITY, NEAR THE ANASTOMOSIS, BEFORE THE CLOSURE OF THE ABDOMINAL INCISION. NO PROTECTIVE STOMA WAS MADE. IN CONCLUSION, THIS PROSPECTIVE COMPARATIVE STUDY DEMONSTRATED THAT MODIFIED DOUBLE-STAPLING TECHNIQUE HAS A BETTER SHORT-TERM OUTCOME IN REDUCING ANASTOMOTIC LEAKAGE COMPARED WITH DOUBLE-STAPLING TECHNIQUE. THEREFORE, THIS TECHNIQUE COULD BE AN ALTERNATIVE APPROACH TO MAXIMIZE THE BENEFIT OF LAPAROSCOPIC ANTERIOR RESECTION ON PATIENTS WITH MIDDLE AND HIGH RECTAL CANCER. THE "DOG-EARS" CREATE STAPLED CORNERS POTENTIALLY ISCHEMIC, SINCE THEY REPRESENT THE AREA WITH HIGH INCIDENCE OF ANASTOMOTIC LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93572 GREEN RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036001782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other