MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LC RELOAD 100MM BLUE; STAPLE, IMPLANTABLE

Catalog Number	GLCR100B
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 12/12/2024.D4 batch # unk.B3: only event year known: 2024.H6: health effect ¿ clinical code gastrointestinal system (e10).An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.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: what is meant by ¿did not clip properly¿? was the ostomy planned? or was this a result of the device malfunction? what was the tissue thickness? what did the staple formation look like after the firing? was there any difficulty firing the device? did the device have trouble closing? were there malformed staples? 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 that during a colon procedure the surgeon said when using the stapler, it did not clip properly.They ended up doing an ostomy.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/3/2024.Additional information was requested, and the following was obtained: what is meant by "did not clip properly"? staples after firing didn't form b shape, remained in "goal post" formation.Was the ostomy planned? or was this a result of the device malfunction? ostomy was planned per surgeon.What was the tissue thickness? surgeon indicated that tissue fell under normal thickness range.What did the staple formation look like after the firing? staples remained in "u" shape and did not form properly.Did the device have trouble closing? no difficulty closing the device.Were there malformed staples? yes, the staples in the tissue were still in the "u" shape.

• Brand Name: ECHELON LC RELOAD 100MM BLUE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20915514
• Report Number: 3005075853-2024-09472
• Device Sequence Number: 7824384
• Product Code: GDW
• UDI-Device Identifier: 10705036027850
• UDI-Public: (01)10705036027850(17)270930(10)315D14
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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: GLCR100B
• Device Lot Number: 315D14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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