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

Catalog Number	TX60B
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abscess (1690); Adhesion(s) (1695); Necrosis (1971); Hernia (2240)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 7/8/2025.D4 batch # unk.H6: health effect ¿ clinical code gastrointestinal system (e10).B3: only event year known: 2021.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient with history of copd, coronary artery disease, obesity and surgically treated prostate cancer who underwent right hemicolectomy, incisional hernia repair, and partial omentectomy to treat cecal and ascending colon cancer.Operative note indicates mass was just proximal to the cecum and the ascending colon and the right colon was mobilized to the level of the hepatic flexure.The ileum was also mobilized given extensive adhesions.¿ligasure¿ was used to transect to divide the right colon and a ¿75mm gia stapler¿ was used to transect the ileum and mid transverse colon and to create the anastomosis.A ¿tx60¿ was used to close the enterotomy sites.No difficulties were noted with any staplers.4 days post-operatively, the patient showed signs of leak and underwent an exploratory laparotomy with creation of ileostomy and drainage of intra-abdominal abscess.Operative note indicates a ¿4 mm area of dehiscence of bowel consistent with the site of his anastomotic leak.¿ an ileostomy was created and patient was discharged one week later.10 days following discharge, he presented with a leaking stoma.Post-operatively, the patient¿s ileostomy had become necrotic and patient developed a right lower quadrant parastomal hernia and ¿4.0 x1.7 cm abscess adjacent to the stoma on the right, and a 2.2 x 2 cm abscess to the left of the stoma.Patient underwent an exploratory laparotomy, extensive lysis of adhesions, small bowel resection, and ileostomy revision.The ileostomy was found to be necrotic from the fascia to the skin level, with two areas of full-thickness recurrent necrosis resulting in stool drainage and breakdown of the ileostomy.He was discharged 6 days later.No information regarding patient¿s current condition is available.There were patient consequences: re-op, leak post operatively.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/17/2025.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 22439856
• Report Number: 3005075853-2025-05258
• Device Sequence Number: 16953430
• Product Code: GDW
• UDI-Device Identifier: 10705036003342
• UDI-Public: (01)10705036003342(17)260430(10)293A94
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: TX60B
• Device Lot Number: 293A94
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male