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

Catalog Number	TLC10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 2/18/2025.D4 batch #940c24.B3: exact date is unk.Assumed first day of the month.Investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.The analysis results found that the tlc10 device was received with the firing knob detached and with no reload present.No functional test could be performed due to the condition of the device.No conclusion could be reached as to what caused the firing knob to be dislodged.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: using a sterile technique, remove the instrument from the package.To avoid damage, do not flip the instrument into the sterile field.Return the firing knob to the original ¿return knob here¿ position and ensure a click is heard.The reload cannot be inserted unless the firing knob is in its original position.Separate the instrument halves by pulling open the alignment/locking lever.Pull upward on the gripping surface and unsnap the used reload from the cartridge fork.Properly discard the used reload.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 940c24, and no non-conformances were identified.
Event or Problem Description
It was reported that during colectomy procedure; they had a tlc10 stapler disengage incorrectly.Got another stapler to complete the procedure.No surgical delay was reported.There was no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21403155
• Report Number: 3005075853-2025-01252
• Device Sequence Number: 12841447
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: (01)10705036003120(17)290331(10)940C24(21)
• 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
• Report Date (Section B): 02/18/2025

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 Catalogue Number: TLC10
• Device Lot Number: 940C24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown