MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	CDH29A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Obstruction/Occlusion (2422)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: this complaint is from a literature source.The following literature cite has been reviewed: tulina i, tsugulya pb, kim v, he m, balaban v, tsarkov p.Short- and long-term outcomes of 3-row vs 2-row circular staplers for low colorectal anastomosis after total mesorectal excision: a single-center, randomized, single-blind, phase iii trial (threestapler study).Dis colon rectum.2026 oct 1;69(10):2500-2510.Doi: 10.1097/dcr.0000000000004381.Epub 2026 aug 10.Pmid: 42572962; pmcid: pmc13585166.This study compared the efficacy of 3-row versus 2-row circular staplers in reducing anastomotic leakage rates.A total of 154 patients underwent low anterior resection with total mesorectal excision and were randomly assigned into 2 groups in a 1:1 ratio.The end-to-end colorectal anastomosis was performed using either a manual 2-row circular stapler (ethicon cdh29a, 29¿mm) or a manual 3-row circular stapler (mirus mcs-29r3, 29¿mm).Reported complications: 2-row circular stapler (ethicon cdh29a, 29¿mm) n=12 anastomotic leakage treatment: not reported.N=2 anastomotic stricture treatment: not reported.In conclusion, the 3-row stapler was noninferior to the 2-row stapler in preventing anastomotic leakage.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/25/2026 d4: batch # unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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.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.

• Brand Name: N/A
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50896692
• Report Number: 3005075853-2026-07995
• Device Sequence Number: 12219724
• Product Code: GDW
• UDI-Device Identifier: 10705036003465
• UDI-Public: 10705036003465
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Type of Report: Initial

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 Catalogue Number: CDH29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown