BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH STEALTH CIR STAPLER

    MDR report key: 7011764 · Received November 8, 2017

    Report

    Report Number
    3005075853-2017-05975
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    October 11, 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 LEAKS EXPERIENCED DURING THE STUDY RELATED TO AN ALLEGED DEFICIENCY OF AN ETHICON DEVICE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: "TITLE: REGENERATED OXIDIZED CELLULOSE REINFORCEMENT OF LOW RECTAL ANASTOMOSIS: DO WE STILL NEED DIVERSION? AUTHORS: KHALED M. MADBOULY, M.D., PH.D., AHMED HUSSEIN, M.D., PH.D., WALEED OMAR, M.D., PH.D., MOHAMED FARID, M.D., PH.D. CITATION: DIS COLON RECTUM 2010; 53: 889¿895. DOI: 10.1007/DCR.0B013E3181D3206E. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF OXIDIZED REGENERATED CELLULOSE (OC) REINFORCEMENT ON THE OUTCOME OF OW RECTAL ANASTOMOSIS. THE STUDY POPULATION COMPRISED 108 ADULTS WITH MID AND LOW RECTAL CANCER WHO PRESENTED BETWEEN MAY 2003 AND DECEMBER 2008. PATIENTS WERE SELECTED IF THEY WERE AMENABLE TO LOW ANTERIOR RESECTION AND HAD COLORECTAL OR COLOANAL ANASTOMOSIS. A TOTAL OF 71 WERE INCLUDED IN THE STUDY AND RANDOMIZED. STRAIGHT LOW COLORECTAL ANASTOMOSIS USING A 29-MM CIRCULAR STAPLER (ETHICON ENDO-SURGERY) WAS PERFORMED BETWEEN THE DESCENDING COLON AND THE RECTAL STUMP WITHOUT PROXIMAL DIVERSION. PATIENTS WERE PROSPECTIVELY RANDOMIZED INTO 2 GROUPS. IN THE FIRST GROUP, THE ANASTOMOSES WERE REINFORCED USING OC (OCR: N=33; 19 MEN, 14 WOMEN MEAN AGE 55 YEARS) (SURGICEL NU-KNIT, ABSORBABLE HEMOSTAT, ETHICON ENDO-SURGERY). IN THE SECOND GROUP, NO REINFORCEMENTS WERE PERFORMED (NR: N=38; 20 MEN, 18 WOMEN; MEAN AGE 57 YEARS). IN THE OCR GROUP, 2 RINGS OF OC WERE CUT WITH THE EXACT CIRCUMFERENCE OF BOTH THE STAPLER TOP RING AND THE ANVIL BOTTOM RING. ONE RING WAS FIXED TO THE STAPLER AND THE OTHER, TO THE BOTTOM RING OF THE ANVIL USING STERI-STRIPS. STUDY OUTCOMES INCLUDE: BLEEDING FROM THE STAPLE LINE (NR, N=4), INCOMPLETE DOUGHNUT RING (OCR, N=1; UNDERWENT PROXIMAL DIVERSION), AIR LEAK DURING ANASTOMOTIC TESTING AT SURGERY (OCR, N=1; NR, N=1; BOTH UNDERWENT PROXIMAL DIVERSION), PELVIC HEMATOMA (NR, N=3), ANASTOMOTIC LEAKS (OCR, N=2; NR, N=6), WOUND INFECTION FROM ANASTOMOTIC LEAK (OCR, N=2; NR, N=3 [ALL WERE PELVIC ABSCESSES ¿ MANAGED BY CT-GUIDED DRAINAGE AND INTRAVENOUS ANTIBIOTICS]), GENERALIZED PERITONITIS FROM ANASTOMOTIC LEAK (NR, N=3 [UNDERWENT REEXPLORATION ¿ 2 WERE PROXIMALY DIVERTED, 1 RECEIVED PERITONEAL LAVAGE AND HAD AN END COLOSTOMY AFTER CLOSURE OF THE RECTAL STUMP]), PROLONGED ILEUS (OCR, N=4; NR, N=3), ABDOMINAL WOUND DEHISCENCE (OCR, N=1). THE DATA DEMONSTRATE THAT OC REINFORCEMENT OF LOW RECTAL ANASTOMOSIS SIGNIFICANTLY DECREASES THE RISK OF POSTOPERATIVE LEAK IN LOW RECTAL ANASTOMOSIS AND PROBABLY LIMITS THE NEED FOR PROXIMAL DIVERSION. OC ALSO DECREASES THE NEED FOR SURGICAL INTERFERENCE IN THE CASE OF A LEAK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791249 ENDOPATH STEALTH CIR STAPLER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention