BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 12281851 · Received August 5, 2021

    Report

    Report Number
    3005075853-2021-04500
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    June 12, 2020
    Report Date
    July 6, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: PUBLICATION YEAR OF 2020. BATCH # UNK. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE TO INCLUDE PATIENT MORTALITY?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SEMIMECHANICAL ANASTOMOSIS DURING OESOPHAGECTOMY REDUCES LEAKS AND STENOSIS: A PROPENSITY SCORE MATCHED ANALYSIS AUTHORS: ELENA MAZZA, PAOLO STRIGNANO, FABRIZIO FOP, DAMIANO PATRONO, GIORGIA CATALANO, MAURO SALIZZONI AND RENATO ROMAGNOLI. CITATION: INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY (2020); 31:182¿190. DOI:10.1093/ICVTS/IVAA065. THE AIM OF THIS SINGLE-CENTRE RETROSPECTIVE COHORT STUDY WAS TO COMPARE THE SURGICAL OUTCOMES OF SM AND TM ANASTOMOSES DURING OESOPHAGECTOMY REGARDLESS OF THE SURGICAL ACCESS AND OF THE TYPE OF OESOPHAGEAL REPLACEMENT. IN THE PERIOD 1 JANUARY 1998 TO 15 APRIL 2018, A TOTAL OF 312 PATIENTS WHO UNDERWENT PARTIAL AND SUBTOTAL OESOPHAGECTOMIES FOR MALIGNANT AND BENIGN DISEASES WERE INCLUDED IN THE ANALYSIS. THE SERIES WAS SPLIT INTO A TRAINING PERIOD (JANUARY 1998¿SEPTEMBER 2015), WHEN BOTH TM (90 PATIENTS; 71 MALE AND 19 FEMALE; MEDIAN AGE = 64 YEARS; AGE RANGE = 22-83; MEDIAN BMI = 23) AND SM TECHNIQUES (122 PATIENTS; 97 MALE AND 25 FEMALE; MEDIAN AGE = 64; AGE RANGE = 39-87; MEDIAN BMI = 24) WERE USED, AND A VALIDATION PERIOD (OCTOBER 2015¿APRIL 2018) WITH A TOTAL OF 100 PATIENTS (75 MALE AND 25 FEMALE; MEDIAN AGE = 69 YEARS; AGE RANGE = 23-89; MEDIAN BMI = 24), DURING WHICH SM TECHNIQUE BECAME STANDARD PRACTICE. SM ANASTOMOSIS WAS REALIZED IN A SIDE-TO-SIDE FASHION USING A LINEAR STAPLER FOR THE POSTERIOR SIDE (ETHICON ENDOPATH ETS-FLEX ARTICULATING LINEAR CUTTERS 35/45MM). REPORTED COMPLICATIONS INCLUDED OPERATIVE MORTALITY (N=10); POSTOPERATIVE COMPLICATION GRADE 1 (N=13); POSTOPERATIVE COMPLICATION GRADE 2 (N=47); POSTOPERATIVE COMPLICATION GRADE 3A (N=3); POSTOPERATIVE COMPLICATION GRADE 3B (N=6); POSTOPERATIVE COMPLICATION GRADE 4 (N=15); POSTOPERATIVE COMPLICATION GRADE 5 (N=7); ANASTOMOTIC LEAK TYPE 1 (N=1) AND ANASTOMOTIC LEAK TYPE 2 (N=1); ANASTOMOTIC STRICTURES/STENOSIS (N=1) WHICH WAS TREATED BY ENDOSCOPIC DILATATION; HAEMORRHAGE (N=2), PERITONITIS (N=2), AND UNKNOWN EVENT/OTHER (N=3) WHICH REQUIRED REOPERATION/REINTERVENTION. IN CONCLUSION, SM ANASTOMOSIS CAN BE SAFELY USED BOTH AT NECK AND INTRATHORACIC WITH ALL KINDS OF OESOPHAGEAL SUBSTITUTES AND IS SUPERIOR TO THE TM TECHNIQUE IN TERMS OF INCIDENCE OF ANASTOMOTIC LEAKS AND STRICTURES. A PROSPECTIVE RANDOMIZED CLINICAL TRIAL SHOULD BE CARRIED OUT TO VALIDATE THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180250 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1