MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Catalog Number	ECS33A
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Sepsis (2067)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the risk manager received notice of litigation from attorney for patient with history of diverticulitis who underwent sigmoid resection for ¿the removal of a large mass in his colon.¿ pleading further alleges that on post operative day five, patient was diagnosed with sepsis and rushed to the operating room for emergency surgery to repair a colorectal anastomotic leak.It is alleged that that the anastomotic leak was caused by an area of non-functional staples.Pleading further states patient had to undergo numerous other surgeries, including ¿the placement of a very large area of mesh throughout his entire abdomen.¿.
Additional Manufacturer Narrative
(b)(4).Date of event is 2019, event day and month unknown.Captured as (b)(6) 2019.Batch #: unknown.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: 03/31/2023.Medical records received.Please see attached.
Additional Manufacturer Narrative
(b)(4).Additional information received: surgeon in this matter was recently deposed and indicated the circular stapler used was the (b)(6).

• Brand Name: ILS 33MM, 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: 15880209
• Report Number: 3005075853-2022-08203
• Device Sequence Number: 19452780
• Product Code: GDW
• UDI-Device Identifier: 10705036012412
• UDI-Public: 10705036012412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K940967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2024

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: ECS33A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 03/28/2023; 03/28/2024
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 03/31/2023; 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male