MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: unknown.Batch # unknown.(b)(4).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.

Event Description

It was reported via journal article: title: laparoscopic restorative proctocolectomy: safety and critical level of the ileal pouch anal anastomosis.Authors: s.E.Duff; p.M.Sagar; m.Rao; d.Macafee; t.El-khoury.Citation: the association of coloproctology of great britain and ireland.14, 2011; 883¿886; doi: doi:10.1111/j.1463-1318.2011.02810.X.The aim of this prospective study was to report the longer-term results of laparoscopic-assisted restorative proctocolectomy (rpc), with particular reference to safety and the level of the stapled ileal pouch-anal anastomosis (ipaa).From july 2006 to july 2010, 75 patients (male=34; median age= 35 years, age range=15 ¿ 72 years) underwent rpc with ipaa.During the procedure, the rectum was mobilized laparoscopically as far as the pelvic floor, then a small (6 cm) pfannenstiel incision was made to complete the pelvic dissection and to allow placement of a linear contour device (ethicon) to divide the rectum at the pelvic floor level.The pouch was constructed using two limbs of 20 cm of ileum with two to three firings of a linear stapler (tlc 75; ethicon) and a double stapled end-to-end anastomosis was constructed with a circular stapler (els 29; ethicon).Reported early postoperative complications included pelvic abscess/collection (n=6) which 4 patients were readmitted; ileus/small bowel obstruction (n=5) in which 2 patients were readmitted and managed conservatively; minor wound infection (n=4) in which 2 patients were readmitted; postoperative bleedings (n=1); mesenteric thrombosis (n=1); abdominal pain (n=3) which the patients were readmitted; radiological leakage (n=5); small leak from blind end of the j pouch (n=1); anastomotic stricture (n=1); long -term complication included pouchitis (n=18); pouch-anal anastomotic stricture (n=9) which required dilatation under anaesthetic; poor function (n=6) in which two patients required an ileostomy; small bowel obstruction secondary to a band adhesion (n=1) which required a laparotomy in the second trimester of pregnancy.In conclusion, in laparoscopic-assisted rpc a limited pfannenstiel incision allows safe construction of the ipaa at an appropriate level.Laparoscopic rpc is safe and the emerging long-term follow-up data show the benefit of this approach, with very low rates of small bowel obstruction and incisional hernia formation.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9985360
• MDR Text Key: 188539644
• Report Number: 3005075853-2020-02277
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention