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	Failure to Anastomose (1028); Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via journal article: title: textbook outcome after gastrectomy for gastric cancer is associated with improved overall and disease-free survival.Authors: candan cetinkaya-hosgör, philippa seika, jonas raakow, dino kröll i id eva maria dobrindt, max magnus maurer, friederike martin, ramin raul ossami saidy, peter thuss-patience, johann pratschke, matthias biebl, and christian denecke citation: journal clinical medicine.2023 https://doi.Org/10.3390/.The aim of this study was to investigate the effect of the surgical outcome on survival and to identify patient- and procedure-related factors that predict the achievement of textbook outcome (to) in gastric cancer surgery at the institution and to assess the impact of achieving to on overall survival (os) and disease-free survival (dfs).Between january 2017 and december 2021, a total of 99 patients were included in this study.The patients underwent either total gastrectomy, subtotal gastrectomy, or trans-hiatal extended gastrectomy for gastric cancer, all with curative intent.Some surgeries were performed open and others laparoscopic.Circular anastomosis was performed utilizing either an echelon circulartm powered stapler (johnson & johnson medical gmbh, ethicon, irvine, ca, usa) or the dst series¿ eea¿ orvil¿ device (medtronic, minneapolis, mn, usa) introduced on the previously made purse-string into the esophagus.Linear anastomosis is performed with a 60 mm linear stapler (echelontm+ stapler, johnson & johnson medical gmbh, ethicon, irvine, ca, usa), and the posterior wall of the esophagus and the anti-mesenteric side of the jejunum are anastomosed side by side with the overlap method.Reported complications included: echelon circulartm powered stapler (ethicon endosurgery), echelontm+ stapler (ethicon endosurgery), infectious complications (n=?), treatment: not reported, anastomotic leak (n=?).Treatment: not reported drainage (n=?).Treatment: requiring reinterventions ssi (n=?).Treatment: not reported gi bleeding, (n=?).Treatment: not reported pain (n=?).Treatment: not reported.In conclusion, to is a quality indicator that is not exclusively limited to reporting morbidity and mortality, but more comprehensively represents a desired postoperative course.We identified minimally invasive surgery as an independent factor positively influencing to.Furthermore, we showed that to significantly influences os and dfs.The implementation of a uniform to metric would allow for more robust quality control between centers.Therefore, future studies into to definition are warranted.
Additional Manufacturer Narrative
(b)(4) date sent: 3/11/2025 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/18/2025.H6.Medical device problem code.H6.Health effect - impact code.

• Brand Name: ILS 21MM CURVED
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 21574693
• Report Number: 3005075853-2025-01898
• Device Sequence Number: 15510383
• Product Code: GDW
• UDI-Device Identifier: 10705036003441
• UDI-Public: 10705036003441
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/18/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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
• Patient Sex: Unknown