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

Catalog Number	CDH21A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: title: endoscopy vs esophagram for routine anastomotic evaluation following mckeown esophagectomy: a retrospective cohort study author's: sheng h., yan h., caiyan f., zhichao l., jiadi w., daofeng w., binyang x., jiyang c., huilin s., xiaobin c., bin l., qianwen l., weidong w., hong y.Citation: international journal of surgery.2026.Doi: 10.1097/js9.0000000000005547.The aim of this study is to report the enrolled 246 patients with esophageal cancer who underwent mckeown esophagectomy at sun yat-sen university cancer center between 2022 and 2023.107 patients who underwent routine es for anastomotic evaluation were included in the es group, while 139 patients.Circular stapler (ees) was used in an end-to-side esophagogastric anastomosis, and vicryl plus (eth) was used in anastomosis in inverted and reinforced with full-thickness interrupted.Reported complications: cdh21a/cdh25a circular staple (ees) vicryl plus (eth) es group (n=107).Anastomotic leakage (al) (n=8) treatment: not reported.Ep group (n=139) anastomotic leakage (al) (n=17) treatment: not reported.In conclusion, es might be superior to ep for the routine evaluation of anastomosis after mckeown esophagectomy.Further studies are warranted.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/13/2026.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.B3: only event year known: 2026.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: 50233983
• Report Number: 3005075853-2026-06583
• Device Sequence Number: 10297234
• Product Code: GDW
• UDI-Device Identifier: 10705036003441
• UDI-Public: 10705036003441
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/13/2026

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: CDH21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/13/2026
• 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