MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*75MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number TLC75

Device Problems Failure to Cut (2587); Failure to Fire (2610)

Patient Problem Failure to Anastomose (1028)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent 12/4/2023.D4 batch # unk.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.Additional information was requested, and the following was obtained: is it the surgeon¿s usual practice to fire a 75 mm device on the appendix? can details be provided on how the procedure was performed given the device is for open procedure and the event was reported to be lap appendectomy? why was the procedure converted? was the tlc75 device used prior to conversion to open? answer: the procedure was planned laparoscopic and started that way, but was converted to open.Normal practice is to do so laparoscopic with a endocutter.Why the doctor converted to open is not known.Tlc was used after the decision was made to open.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 Description

It was reported that during a laparoscopic appendectomy the procedure had to convert to open.The surgeon used tlc75 to transect the appendix.First firing went perfectly, but second firing miss fired.It was noted that on the second firing the stapler cut and stapled distal.It cut and stapled proximal.But in the middle of the cut line the reload stapled, but did not cut.They opened an additional reload and the stapler jammed (on the third firing).A new stapler was opened and the case was completed with no issues.The tech said the stapler was directly across the appendix, and it did not appear that tissue was "milking" from the center of the reload.

Manufacturer Narrative

(b)(4).Date sent: 1/24/2024 additional information received: why was the procedure was converted? were there difficulties during the lap approach? answer: why the procedure was converted is not known.Difficulties with lap were not known.The complaint is for an open device failing and has nothing to do with surgical approach.

• Type of Device: 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 ; PR ; 3035526892
• MDR Report Key: 18256272
• MDR Text Key: 329603384
• Report Number: 3005075853-2023-08994
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036013211
• UDI-Public: 10705036013211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TLC75
• Device Lot Number: 624C41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TCR75(X2).
• Patient Outcome(s): Required Intervention