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

Catalog Number	TLC10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.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.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: 1.Please provide more details for "the reload was misfired" : 1.) it was mis fired while firing the reload.2.Did the device staple? : 2.) no, it didn¿t staple.3.If the device stapled, was the staple line complete? : 3.) no, the staple line was not completed.4.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? : 4.) no, as i mentioned it didn¿t.5.Did the device cut? : 5.) yes, it cut.6.If the device cut, was the cut line complete? : 6.) yes, the cut was complete.7.Were the cut line and staple lines equal? : 7.) no.8.Was the device fired across a staple line? : 8.) no 9.Did the reload lock out and would not work? : 9.) yes, it was locked out and not worked.10.Did the reload begin to staple and cut, but then jammed? : 10.) yes.11.Did the device staple, but there was no cut line? : 11.) no, it didn¿t staple, but there was cut line.12.How was the procedure completed? : 12.) yes, it was completed while using suture 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 unknown procedure while firing the reload was misfired.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/28/2024.D4: batch #448a60.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 determined that the tlc10 device was received with no apparent damage and with a reload loaded on the device.The reload was received with the swing tab in the unlocked position and left gripping surface broken and not returned making the reload nonfunctional.The reload had the proximal 6 driver up without staples, and the remaining drivers down with staples present.In addition, corrosion and fluids were noted in some parts of metal area and mechanism knob causing the knob stiff.However, the device was cleaned and the device was tested for functionality with a test reload.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple form release criteria.The event reported was confirmed and it is related to improper use of the device.As it is possible that the firing knob was not returned to its home position while loading the reload.The condition of the broken gripping surface is consistent with an improper loading technique.When loading the cartridge in the device, make sure the cartridge is inside the channel track and the proper loading technique.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 448a60, and no non-conformances related to the reported complaint condition 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: 19750486
• Report Number: 3005075853-2024-05120
• Device Sequence Number: 13047746
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)260930(10)X95C8R
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/28/2024

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: 09/30/2026
• Device Catalogue Number: TLC10
• Device Lot Number: X95C8R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown