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

Catalog Number	CDHXX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Insufficient Information (4580)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 3/18/2025.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.Additional information was requested, and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.No further information will be provided because we can¿t get any additional information from the author.Additional information was requested, and the following was obtained: could you please provide more details on how each issue was addressed for the following events (occur intra-operatively or post-operatively, treatment, medical or surgical interventions performed: anastomotic leakage (n=?), anastomotic stricture (n=?), surgical site infection (n=?).Does the surgeon believe that was a result of either of the ethicon devices? anastomotic leakage (n=?), anastomotic stricture (n=?), surgical site infection (n=?).Please provide further details.Is it known whether or not the issues noted were previously reported to ethicon customer quality? if yes, do you have the product complaint submission record numbers? no further information will be provided because we can't get any additional information from the author.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.
Event or Problem Description
It was reported via journal article: title: comparison of the subtotal and narrow gastric conduit for cervical esophagogastrostomy after esophagectomy in esophageal cancer patients: a propensity score-matched analysis.Author: ken sasaki 1 g, yusuke tsuruda 1, masataka shimonosono1, masahiro noda 1, yasuto uchikado1 - ltaru omoto1, tetsuro setoyama 1, daisuke matsushita 1, takaaki arigami 1, kenji baba 1, hiroshi kura hara 1, takao ohtsuka.Citation: https:/ /doi.Org/ 10.1007 /s 10388-023-01027-7.A retrospective study the aim is to determine the optimal gastric conduit type investigated and compared the postoperative complications between ngc and sgc used in cervical circular-tapered esophagogastrostomy after esophagectomy through a propensity score-matched analysis.Between 2008 and 2022, 577 consecutive esophageal cancer patients who underwent esophagectomy and cervical circular-stapled esophagogastrostomy were enrolled in this study.Results of the 577 patients, 77 were included each in the sgc and ngc clinical characteristics did not differ between the two groups.The anastomotic leakage rate was significantly lower in the sgc group than in the ngc group (5%).There were (n=499) patients with thoracic esophageal cancer underwent subtotal esophagectomy and cervical circular-stapled esophagogastrostomy.(n= 23) patients underwent reconstruction using the colon, (n= 18) patients underwent linear stapled or hand-sewn cervical esophagogastrostomy, and (n= 16) patients had residual tumors.Proximate® curved intraluminal stapler 21-25-mm (ethicon endosurgery, cincinnati, oh, usa was used during esophagogastrostomy was performed.Reported complications: proximate® curved intraluminal stapler 21-25-mm (ethicon endosurgery, cincinnati, oh, usa), anastomotic leakage (n=?), anastomotic stricture (n=?), surgical site infection (n=?).In conclusion, in cervical circular-stapled esophagogastrostomy after esophagectomy, sgc was superior to ngc in terms of reducing the risk of anastomotic leakage, but the risk for anastomotic stenosis needs to be resolved.

• 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: 21631566
• Report Number: 3005075853-2025-02000
• Device Sequence Number: 15337433
• Product Code: GDW
• UDI-Device Identifier: 10705036003441
• UDI-Public: 10705036003441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/18/2025

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?: No
• 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: 03/18/2025
• 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