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

Model Number	TCR10
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), date sent: 7/5/2023, 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.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.Additional information was requested, and the following was obtained: 1.Could you please clarify how long was the delay (hours/minutes)? about 5-10 minutes.2.Was there any patient consequence as a result of the procedure being prolonged? no.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 ileostomy closure and after using a linear stapler, the surgeon realized that on one side of the application, there was no staple line.So 2 lines on one side of the cutting line, and 0 line on the other side.The surgeon had to do everything again manually.There was a surgery delay due to the reported event.The procedure was successfully completed.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/10/2023.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/25/2023.The lot# 427c93 history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/7/2023 d4: batch #963a66.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample revealed that one tcr10 reload was received with no apparent damage.The reload was returned fully fired.No functional test could be performed due to the condition of the reload.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: 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.Event described could not be confirmed as the cartridge was received fully fired.A manufacturing record evaluation was performed for the finished device batch number 963a66, 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: 17259233
• Report Number: 3005075853-2023-04602
• Device Sequence Number: 8061761
• Product Code: GDW
• UDI-Device Identifier: 10705036003045
• UDI-Public: 10705036003045
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2023

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 Model Number: TCR10
• Device Catalogue Number: TCR10
• Device Lot Number: 427C93
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 07/28/2023; 10/19/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 07/25/2023; 08/10/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown