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

Catalog Number	TX30G
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/19/2023 d4: batch # unk 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 number was provided therefore a device history could not be done.Additional information provided: the firing trigger was grasped, but the staple was not confirmed during the operation nor x-ray.Planned colostomy was performed.There was no staple on x-ray except form the anastomosis device¿s staple.The procedure was anterior resection.The device was used on the rectum.Additional information was requested, and the following was obtained: how was the operation changed to complete the case? => the staple was not left on the target tissue, so the tissue was pulled from the anus side and the purse suturing was performed and sst anastomosis was performed.Was meant by staples could not be deployed? =>the staples were not deployed.Was it confirmed that the dark firing handle was completely closed prior to the transection of tissue? =yes.What was the experience with the device for the surgeon? =>the additional information was not provided.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 an open rectum resection, the device was fired, but the staple could not be deployed.The surgeon did not notice about that and cut the rectum by the knife.The staple was not left on the target tissue, so the tissue was pulled from the anus side and the purse suturing was performed and sst anastomosis was performed.The operation was changed to complete the case.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/30/2023.D4: batch #u5ez4t.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the tx30g device arrived with no apparent damage and with a reload loaded on the device.The reload was received fully fired.The device was tested for functionality with a test reload and it fired and formed all the staples as intended.The staple line was complete, and the staples meet the staple form release criteria as part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: attempting to force the trigger to complete the closing stroke with too much tissue or thickened tissue may result in poor staple formation with the loss of staple line integrity and subsequent leakage, disruption, or poor healing.In addition, instrument damage or failure may result.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number u5ez4t, and no non-conformances were identified.

• 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: 17967546
• Report Number: 3005075853-2023-07676
• Device Sequence Number: 7754367
• Product Code: GDW
• UDI-Device Identifier: 10705036003328
• UDI-Public: 10705036003328
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: TX30G
• Device Lot Number: U5EZ4T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown