MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. N/A; STAPLE, IMPLANTABLE

Catalog Number	CDH25A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Obstruction/Occlusion (2422); Insufficient Information (4580)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: le z, zhang z, zhou t, liu m.Esophagojejunal anastomosis after totally laparoscopic total gastrectomy: ¿-shaped versus reverse puncture device anastomosis.Ann ital chir.2025 oct 10;96(10):1400-1408.Doi: 10.62713/aic.4221.Pmid: 41099107.This study aimed to compare the advantages of -shaped anastomosis with reverse puncture device (rpd) anastomosis following totally laparoscopic total gastrectomy (tltg).Between 1 january 2020 and 1 january 2024, a total of 133 patients with gastric cancer who underwent totally laparoscopic total gastrectomy (tltg).Patients were categorized into a -shaped group (67 patients) and an rpd group (66 patients) according to the esophagojejunal anastomosis method.There were 38 (57%) males and 29 (43%) females in the -shaped group with the mean age of 64.9 ± 8.9 years old while there were 39 (59%) males and 27 (41%) females in the rpd group with the mean age of 66.3 ± 7.3 years old.A purse-string suture was secured by applying traction to the sutures prefixed on the anvil, and the stump of the esophagus was closed with a 60-mm ethicon linear stapler (fig.1c, d).The jejunum, approximately 15¿25 cm distal to the ligament of treitz, was selected to ensure that there was no tension after traction.The circular stapler (ethicon cdh25a, ethicon endo-surgery, cincinnati, oh, usa) was then introduced through the roux limb.The anvil head and circular stapler (ethicon cdh25a, ethicon endosurgery, cincinnati, oh, usa) were connected.The jejunum stump was closed with a 60-mm ethicon linear stapler (ec60a+ecr60w, ethicon endo-surgery, cincinnati, oh, usa) after esophagojejunostomy.The roux limb was anastomosed to the biliopancreatic limb about 45¿50 cm below the esophagojejunostomy by using another two staplers (ec60a+ecr60w, ethicon endosurgery, cincinnati, oh, usa) under laparoscopy.Following completion of the d2 lymphadenectomy, duodenal transection was conducted using a 60-mm ethicon linear stapler (ec60a+ecr60w, ethicon endo-surgery, cincinnati, oh, usa).A side-to-side anastomosis was then created between the right wall of the esophagus and the antimesenteric wall of the jejunum using a second ethicon linear stapler (ec60a+ecr60b, ethicon endo-surgery, cincinnati, oh, usa) (fig.2d).The esophagojejunostomy anastomo-sis (e-j) was inspected through the entry hole (fig.2e), which was subsequently closed with a third linear stapler (ec60a+ecr60b, ethicon endo-surgery, cincinnati, oh, usa) (fig.2f).The roux limb was anastomosed to the biliopancreatic limb about 45¿50 cm below the esophagojejunostomy using another two staplers (ec60a+ecr60w, ethicon endo-surgery, cincinnati, oh, usa) under laparoscopy.The median follow-up duration was 6 months (95% ci: 5.2¿6.8 months).Reported complications: 60-mm ethicon linearstapler ec60a+ecr60w (ethicon endo-surgery), circular staplers ethicon cdh25a (ethicon endo-surgery), ethicon linear stapler ec60a+ecr60b (ethicon endo-surgery), (n=3) patients had ileus, treatment: not reported, (n=9) patients had wound problem, treatment: not reported, (n=3) lymphatic leakage, treatment: not reported, (n=2) patients had clavien¿dindo grade ii, treatment: not reported, (n=4) patients had clavien¿dindo grade iiia, treatment: not reported, (n=?) patients experience bleeding, treatment: not reported.In conclusion, both rpd and -shaped anastomosis are safe and effective techniques.The -shaped anastomosis is recommended as the preferred anastomosis for totally laparoscopic total gastrectomy, and the rpd anastomosis can be applied to gastroesophageal junction cancer with a higher tumor location.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/23/2026.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24966092
• Report Number: 3005075853-2026-03075
• Device Sequence Number: 4978833
• Product Code: GDW
• UDI-Device Identifier: 10705036003458
• UDI-Public: 10705036003458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDH25A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/23/2026
• 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