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

Catalog Number	TLC10
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 2/23/2024.D4: batch #870a33.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, with a reload loaded (a) loaded and a second reload (b) present.Both reloads (a and b) were received with no apparent damage, unfired and the swing tab in the unlocked position.The device was tested for functionality with both returned reloads and fired without any difficulties.However, 4 staples were noted to be missing along the staple line in the reload (b), this staples do not created a fluid path.It is possible that improper handling of the reload caused the staples to fell out, the proper handling instructions should be used when removing and reloading cartridges into the device, please reference the instructions for use.It should be noted that 100% inspection is performed by means of an automated vision system to ensure staples presence; the swing tab is present and unlocked.Please reference the instruction for use for more information.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: place the instrument across the tissue for transection or into the lumen to form an anastomosis.For instruments with no knife, place the instrument across the tissue to be stapled.With the alignment/locking lever in the completely opened position, join the instrument halves together by aligning from either the front, center or back of the instrument.To adjust tissue on the forks before firing, move the alignment/locking lever to the intermediate position.This allows maneuvering of the tissue while the instrument halves are joined.Close the alignment/locking lever completely when the tissue is properly in place.To fire the linear cutter, place the thumb on the firing knob and two fingers on the shoulders of the linear cutter.Fire the instrument by pushing the firing knob completely forward.Completely return the firing knob to the original ¿return knob here¿ position.Separate the instrument halves by opening the alignment/locking lever and remove the instrument.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 870a33, and no non-conformances related to the reported complaint condition were identified.A manufacturing record evaluation was performed for the finished device tlc10 lot number x95k34 and no non-conformances were identified.Manufacturing date: 08/15/2022 expiration date: 07/31/2027 attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: 1.Could you please clarify if there were any patient consequences? 2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? 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 the device feels stiff.

• 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 ; PR ; 3035526892
• MDR Report Key: 18771717
• Report Number: 3005075853-2024-01592
• Device Sequence Number: 20782370
• Product Code: GDW
• UDI-Device Identifier: 10705036003120
• UDI-Public: 10705036003120
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2024

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 Catalogue Number: TLC10
• Device Lot Number: X95K34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TCR10(X2).
• Patient Sex: Unknown