MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE

Model Number	TX30B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Wound Dehiscence (1154); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: unknown.Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported via journal article:title: end-to-end versus end-to-side stapled anastomoses after anterior resection for rectal cancer.Author(s): giuseppe brisinda, md, serafino vanella, md,1 federica cadeddu, md, ignazio massimo civello, md, francesco brandara, md, casimiro nigro, md, pasquale mazzeo, md, gaia marniga, md, and giorgio maria, md.Citation: j.Surg.Oncol.2009;99:75¿79.Doi: 1 0.1002/jso.21182.The aim of this study is the evaluation of early and late postoperative complications in t1¿t2 rectal cancer patients who underwent rectal resection with stapled end-to-end anastomosis or end-to-side anastomosis.Postoperative outcomes of the two procedures, clinicopathological features between patients with and without anastomotic leakage and between patients with and without anastomotic stenosis have been compared.Between jan 1998 and jan 2006, 77 patients with t1¿t2 rectal cancer underwent rectal resection with stapled anastomosis and were divided based on the technique of stapled anastomosis.In 37 patients (20 males and 17 females, mean age: 63.7±9.2 years) an end-to-end anastomosis was performed.In 40 cases (19 males and 21 females, mean age: 67.0±5.9 years) an end-to-side anastomosis was done.In the end-to-side group, the rectal stump was closed with a linear stapler (tx 30b, ethicon endosurgery, llc, cincinnati, oh) in 22 patients, a curved cutter stapler (cs 40g, ethicon endosurgery, llc) was used in 18 cases.Two patients of the end-to-side group experienced anastomotic leakage and were successfully treated with local washouts and antibiotics for 6 weeks.Further complication in this group included wound dehiscence (n=5), wound infection (n=8) and blood transfusion (n=?).We have noted that incomplete or poor bowel preparation, need for blood transfusions and location of anastomosis were statistically related to the development of the anastomotic leakage.End-to-side anastomosis resolves the great problem, particularly for the end-to-end anastomoses, related to the different diameter between the intestinal and the rectal stump.Regarding postoperative surgical complications, end-to-side anastomosis is a safe procedure.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9965126
• Report Number: 3005075853-2020-02181
• Device Sequence Number: 2857720
• Product Code: GDW
• UDI-Device Identifier: 10705036003311
• UDI-Public: 10705036003311
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: TX30B
• Device Catalogue Number: TX30B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention