MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE

Catalog Number	TX60B
Medical Device Problem Codes	Failure to Cut (2587); Failure to Fire (2610); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Firing Problem (4011)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent 11/25/2024.D4 batch # unknown.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.H6: health effect ¿ clinical code gastrointestinal system (e10).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No lot or batch number was provided therefore a device history could not be done.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 low anterior resection procedure that prior to closure the leak test was preformed and a leak was found.On the attempt to fix the leak the surgeon went distal to the first staple line with the tx60b but the stapler was difficult to close and it makes a funny noise.The surgeon "forced" it to fire and when examined, no staples had been deployed and the knife did not cut.A second tx60b was opened.A second leak test was done and no leak was detected.The surgeon was not comfortable with the outcome so erring on the side of caution and did a diversion and created an ileostomy.The patient will return in three to six months to have the stoma closed.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/8/2025.Additional information was requested, and the following was obtained: what is meant by ¿force to fire¿? what was the ¿funny noise¿? what were the indications for surgery? what surgical procedure was performed? did the patient receive any preoperative chemotherapy or radiation? were there any issues experienced with the device in the initial surgical procedure? what healthcare professional fired the device and what is his/her experience with the device? where in the green gap setting scale was the indicator located prior to firing (low-b, middle-b, or high-b)? did the healthcare professional wait 15 seconds after closing the device and then retighten prior to firing? were there any issues with device use/firing? what confirmation was received that the device completed the firing sequence? was the green checkmark visible at the end of the firing? how many counter-clockwise revolutions of the adjusting knob were used to open the device? was there any difficulty removing the device? was a complete transection of the white breakaway washer visually confirmed? were the donuts inspected? if so, please describe.Were there any issues noted with staple formation? if so, please describe the shape and location.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? been trying to connect with all the staff, docs in the room.I have inserviced everyone and the ¿crunch¿ sound and difficulty firing the stapler could have possibly been the safety retaining cap was not removed prior to firing- but would also explain why no staples formed.

• 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: 20777976
• Report Number: 3005075853-2024-08966
• Device Sequence Number: 9052916
• Product Code: GDW
• UDI-Device Identifier: 10705036003342
• UDI-Public: 10705036003342
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: TX60B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TX60B
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown