MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM 30MM; STAPLE, IMPLANTABLE

Model Number	TL30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported via journal article: title: postoperative functional outcomes and complications of partially intraanal canal anastomosis in stapled ileal pouch anal anastomosis for ulcerative colitis author: akira sugita & kazutaka koganei & kenji tatsumi & ryo futatsuki & hirosuke kuroki & kyoko yamada & hideaki kimura & tsuneo fukushima citation: international journal of colorectal disease (2019) 34:1317¿1323 https://doi.Org/10.1007/s00384-019-03322-1 this retrospective study aimed to compare the postoperative bowel function and complications of pica (partially intraanal canal anastomosis) with those of ds-ipaa (double stapling technique ileal pouch anal anastomosis) after 1 year.Between february 1994 and december 2006 a total of 211 ulcerative colitis cases that underwent ds-ipaa, 146 cases (69%) with pica who were confirmed by the squamous epithelium on the posterior part of the distal donuts were included.Sixty-five cases with anastomosis above the anal canal were evaluated as the control (dst).One stage surgery underwent in 95% of pica and 93% of control.Dissection of perirectal tissue towards the anal canal in the pelvic cavity was required to perform anastomosis on this level.In the lithotomy position, the diameter of the anal canal was examined by an instrument to select the optimal size of stapler for the anastomosis.We usually used ils 33 mm (ethicon®) to make a wide lumen on the anastomotic site.On the anterior part of the rectum, dissection was performed to 1¿2 cm above the dentate line to preserve the sensory zone.After confirming the planned dissection line by the finger palpation to each stitch on the dentate from the anus, the anal canal was transected with tl 30 (ethicon®) at 5 mm above the dentate line on the posterior wall and 15¿ 20 mm above the dentate line on the anterior wall.Postoperative median follow-up period was 16.0 months in the pica group and 21.4 months in the control group.Reported adverse events in the pica group included anastomotic leakage (n=13), pelvic sepsis (n=1), late leakage (n=2), anal stricture (n=11), intestinal obstruction (n=24), tube decompression (n=18), anal fistula (n=1) and anal fissure (n=2).Reported adverse events in the control (dst) group included anastomotic leakage (n=7), pelvic sepsis (n=1), anal stricture (n=2), intestinal obstruction (n=7) and tube decompression (n=6).One year after surgery, each group had six bowel movements daily.Nighttime evacuation was found in 16%of pica and in 20% of control.Soiling was found in 1% of pica and 4.8% of control.After one stage operation, anastomotic leakage that needed ileostomy was observed in 0.7% of pica and 3% of control.In conclusion, partially intraanal canal anastomosis (pica) can reduce anal canal mucosa with the same postoperative bowel function and complication rate as ds-ipaa above the anal canal.This procedure may be feasible for uc patients who can tolerate this procedure in terms of decreasing postoperative cancer risk.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11752838
• Report Number: 3005075853-2021-02406
• Device Sequence Number: 14495277
• Product Code: GDW
• UDI-Device Identifier: 10705036013167
• UDI-Public: 10705036013167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TL30
• Device Catalogue Number: TL30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1