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 Code	Insufficient Information (4580)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Csg-f541 study serious adverse event (sae): as part of study "a digital surgical workflow and digital device briefing tool to reduce morbidity and mortality after primary stapled colorectal anastomosis" the following event was reported: sae causality assessment, surgical procedure performed: sigmoidectomy.Sae event term first pod, left foot, compartment syndrome lower leg description of the event: first pod, left foot, compartment syndrome, emergency fasciotomy.Is there a reasonable possibility of relatedness to performed surgical procedure: yes relatedness to surgical equipment used: yes, patient postponing relatedness to study test product: spi digital surgical workflow software/hardware: no relation to study test product: device briefing tool (ddbt checklist): no sae seriousness criteria in- patient hospitalization or prolongation of existing hospitalization: patient was hospitalized on: (b)(6) 2025, patient was discharged on: not yet, medical or surgical intervention to prevent life-threating illness or injury or permanent to a body structure or a body function, sae intensity severe, sae start date on (b)(6) 2025, sae end date: ongoing.Action taken surgical therapy/procedure description of other action taken: fasciotomy patient outcome recovering.
Additional Manufacturer Narrative
(b)(4) date sent 2/24/2025 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.Investigation summary: 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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: 3/5/2025.Corrected data: b1, b2, h1.Additional information was requested, and the following was obtained: what is the exact product code? they use cdhb in the physician's opinion, why is this event probably related to the device and procedure? according to the sae report, the patient had a compartment syndrome due to positioning ('reason: patient positioning').Therefore, it was not a complication due to our circular stapler what was the issue/complaint against the ethicon device? according to the sae report, the patient had a compartment syndrome due to positioning ('reason: patient positioning').Therefore, it was not a complication due to our circular stapler does the surgeon believe the post-operative complications were related to an alleged deficiency of the device or were there other contributing factors to include patient tissue condition? according to the sae report, the patient had a compartment syndrome due to positioning ('reason: patient positioning').Therefore, it was not a complication due to our circular stapler upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• 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: 21446381
• Report Number: 3005075853-2025-01410
• Device Sequence Number: 15243428
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/05/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Race: White