BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 7040248 · Received November 17, 2017

    Report

    Report Number
    3005075853-2017-06177
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    October 20, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A LOT/BATCH WAS NOT PROVIDED, A DEVICE HISTORY COULD NOT BE PERFORMED. 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 BELIEVE THAT ANY POST OPERATIVE COMPLICATIONS MENTIONED IN THE ARTICLE ARE RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LINEAR STAPLED ESOPHAGOGASTROSTOMY IS MORE EFFECTIVE THAN HAND-SEWN OR CIRCULAR STAPLER IN PREVENTION OF ANASTOMOTIC STRICTURE: A COMPARATIVE CLINICAL STUDY AUTHORS: QI-RONG XU & KANG-NING WANG &WEN-PING WANG & KUN ZHANG & LONG-QI CHEN CITATION: J GASTROINTEST SURG (2011) 15:915¿921. DOI 10.1007/S11605-011-1490-1 THIS STUDY WAS DESIGNED TO COMPARE THE RESULTS OF DIFFERENT ANASTOMOTIC TECHNIQUES, INCLUDING LINEAR STAPLED ANASTOMOSIS (LS GROUP), CONVENTIONAL HAND-SEWN ANASTOMOSIS (HS GROUP), AND CIRCULAR STAPLER ANASTOMOSIS (CS GROUP). BETWEEN OCTOBER 2007 AND OCTOBER 2009, 293 PATIENTS WITH ESOPHAGEAL OR CARDIA CARCINOMA UNDERWENT CURATIVE INTENT RESECTION. THERE WERE 166 PATIENTS (143 MEN, 23 WOMEN; MEAN AGE 60.2+/-8.4 YEARS) ENROLLED IN THE LS GROUP, 59 PATIENTS (49 MEN, 10 WOMEN; MEAN AGE 59+/-7.9 YEARS) IN HS GROUP, AND 68 PATIENTS (61 MEN, 7 WOMEN; MEAN AGE 61.3+/-7.6 YEARS) IN CS GROUP. FOR THE OPERATIVE TECHNIQUE, A GASTRIC TUBE OF 5-6 CM IN DIAMETER WAS CREATED BY MEANS OF A 75-MM LINEAR CUTTER STAPLER (PROXIMATE LINEAR CUTTER-TLC75). THE LINEAR STAPLED ANASTOMOSIS INVOLVED USING A LINEAR CUTTER STAPLER TO EXTEND THE ANASTOMOSIS ALONG THE POSTERIOR WALL OF THE ESOPHAGUS WITH THE GASTROTOMY AND ESOPHAGEAL OPENING CLOSED TRANSVERSELY WITH 4/0 ABSORBABLE VICRYL ANTIBACTERIAL SUTURE IN AN EVERTED INTERRUPTED WHOLE-LAYER ANASTOMOTIC MANNER. FOR CIRCULAR STAPLED ANASTOMOSIS, THE CIRCULAR STAPLER OF EES 25 WAS USED. FOR HAND-SEWN ANASTOMOSIS, THE CONVENTIONAL WHOLE-LAYER HAND-SEWN EMBEDDED ESOPHAGOGASTROSTOMY WITH INTERMITTENT 4/0 VICRYL ANTIBACTERIAL SUTURE. COMPLICATIONS INCLUDE: ANASTOMOTIC LEAKAGE (LS GROUP, N=2; HS GROUP, N=2; CS GROUP, N=1), CHYLOTHORAX (HS GROUP, N=1), DIAPHRAGMATIC HERNIA (LS GROUP, N=1), RECURRENT LARYNGEAL NERVE PARALYSIS (CS GROUP, N=1), WOUND INFECTION (LS GROUP, N=2), PULMONARY INFECTION (LS GROUP, N=1; HS GROUP, N=2; CS GROUP, N=2). OUTCOMES INCLUDE: DYSPHAGIA (LS GROUP, N=10; HS GROUP, N=14; CS GROUP, N=20), REFLUX (LS GROUP, N=14; HS GROUP, N=9; CS GROUP, N=14), ANASTOMOTIC STRICTURE (LS GROUP, N=3; HS GROUP, N=5; CS GROUP, N=14). TOTALLY, 2 DILATIONS WERE PERFORMED IN LS GROUP, 9 IN HS GROUP, AND 32 IN CS GROUP FOR THE RELIEF OF DYSPHAGIA SYMPTOM. A BALLOON WAS USED TO DILATE POSTOPERATIVE ANASTOMOTIC STRICTURE. THE STUDY CONCLUDES THAT LINEAR STAPLED ESOPHAGOGASTRIC ANASTOMOSIS IS A SAFE AND EFFECTIVE ANASTOMOTIC TECHNIQUE, WHICH CAN DECREASE THE RATE OF POSTOPERATIVE DYSPHAGIA AND ANASTOMOTIC STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822154 ENDOPATH STEALTH CIR STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention