MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 21MM CURVED; STAPLE, IMPLANTABLE

Catalog Number	CDHXX
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: title: the impact of powered circular staplers on anastomotic leak in left-sided colorectal cancer surgeries author: hayoung lee, yong sik yoon, young il kim, eun jung park, min hyun kim, jong lyul lee, chan wook kim, in ja park & seok-byung lim web address: this retrospective study included colorectal cancer patients at the tertiary referral center from april to october 2023 who underwent anterior or low anterior resection (lar) using a circular stapler.According to energy source, patients were divided into powered and manual groups, which used two powered and four types of manual staplers, respectively.All open, laparoscopic, and robotic approaches were included.Propensity score matching (psm) analysis was used to reduce selection bias.This retrospective study included colorectal cancer patients at the tertiary referral center from april to october 2023 who underwent anterior or low anterior resection (lar) using a circular stapler.According to energy source, patients were divided into powered and manual groups, which used two powered and four types of manual staplers, respectively.All open, laparoscopic, and robotic approaches were included.Propensity score matching (psm) analysis was used to reduce selection bias.During the surgery, the echelon circular¿ powered stapler (ecp, ethicon inc., cincinnati, oh, usa).The reported complications included: (n=4.2%) anastomotic leakage, treatment: not mentioned.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/3/2025.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 device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: ILS 21MM CURVED
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21504270
• Report Number: 3005075853-2025-01647
• Device Sequence Number: 8020523
• Product Code: GDW
• UDI-Device Identifier: 10705036003441
• UDI-Public: 10705036003441
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDHXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Hospitalization
• Patient Sex: Unknown