BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*RL LINEAR STAPLER

    MDR report key: 9965126 · Received April 15, 2020

    Report

    Report Number
    3005075853-2020-02181
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    March 31, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003311
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE:TITLE: END-TO-END VERSUS END-TO-SIDE STAPLED ANASTOMOSES AFTER ANTERIOR RESECTION FOR RECTAL CANCER. AUTHOR(S): GIUSEPPE BRISINDA, MD, SERAFINO VANELLA, MD,1 FEDERICA CADEDDU, MD, IGNAZIO MASSIMO CIVELLO, MD, FRANCESCO BRANDARA, MD, CASIMIRO NIGRO, MD, PASQUALE MAZZEO, MD, GAIA MARNIGA, MD, AND GIORGIO MARIA, MD. CITATION: J. SURG. ONCOL. 2009;99:75¿79. DOI: 1 0.1002/JSO.21182. THE AIM OF THIS STUDY IS THE EVALUATION OF EARLY AND LATE POSTOPERATIVE COMPLICATIONS IN T1¿T2 RECTAL CANCER PATIENTS WHO UNDERWENT RECTAL RESECTION WITH STAPLED END-TO-END ANASTOMOSIS OR END-TO-SIDE ANASTOMOSIS. POSTOPERATIVE OUTCOMES OF THE TWO PROCEDURES, CLINICOPATHOLOGICAL FEATURES BETWEEN PATIENTS WITH AND WITHOUT ANASTOMOTIC LEAKAGE AND BETWEEN PATIENTS WITH AND WITHOUT ANASTOMOTIC STENOSIS HAVE BEEN COMPARED. BETWEEN JAN 1998 AND JAN 2006, 77 PATIENTS WITH T1¿T2 RECTAL CANCER UNDERWENT RECTAL RESECTION WITH STAPLED ANASTOMOSIS AND WERE DIVIDED BASED ON THE TECHNIQUE OF STAPLED ANASTOMOSIS. IN 37 PATIENTS (20 MALES AND 17 FEMALES, MEAN AGE: 63.7±9.2 YEARS) AN END-TO-END ANASTOMOSIS WAS PERFORMED. IN 40 CASES (19 MALES AND 21 FEMALES, MEAN AGE: 67.0±5.9 YEARS) AN END-TO-SIDE ANASTOMOSIS WAS DONE. IN THE END-TO-SIDE GROUP, THE RECTAL STUMP WAS CLOSED WITH A LINEAR STAPLER (TX 30B, ETHICON ENDOSURGERY, LLC, CINCINNATI, OH) IN 22 PATIENTS, A CURVED CUTTER STAPLER (CS 40G, ETHICON ENDOSURGERY, LLC) WAS USED IN 18 CASES. TWO PATIENTS OF THE END-TO-SIDE GROUP EXPERIENCED ANASTOMOTIC LEAKAGE AND WERE SUCCESSFULLY TREATED WITH LOCAL WASHOUTS AND ANTIBIOTICS FOR 6 WEEKS. FURTHER COMPLICATION IN THIS GROUP INCLUDED WOUND DEHISCENCE (N=5), WOUND INFECTION (N=8) AND BLOOD TRANSFUSION (N=?). WE HAVE NOTED THAT INCOMPLETE OR POOR BOWEL PREPARATION, NEED FOR BLOOD TRANSFUSIONS AND LOCATION OF ANASTOMOSIS WERE STATISTICALLY RELATED TO THE DEVELOPMENT OF THE ANASTOMOTIC LEAKAGE. END-TO-SIDE ANASTOMOSIS RESOLVES THE GREAT PROBLEM, PARTICULARLY FOR THE END-TO-END ANASTOMOSES, RELATED TO THE DIFFERENT DIAMETER BETWEEN THE INTESTINAL AND THE RECTAL STUMP. REGARDING POSTOPERATIVE SURGICAL COMPLICATIONS, END-TO-SIDE ANASTOMOSIS IS A SAFE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428721 PROXIMATE*RL LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. TX30B 10705036003311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention