MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Model Number	TLH60
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 field as appropriate.
Event or Problem Description
It was reported that during a thoracotomy, the device didn¿t make the staple line at all.The heart and thoracic surgeon has used this device more than 15 years.This was a first time, when it made the "trick"! the surgery was delayed by 15-minutes.They used an endocutter when this event occurred.Fragments were generated but removed easily without additional intervention.The procedure was completed successfully.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/01/2023.D4: batch # r57l91.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 tlh60 device arrived with no apparent damage with a reload loaded on the device and with the closing trigger in closed position.The reload was returned void of staples.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The staple line was complete and the staples meet the staple form release criteria.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Although there is no direct evidence of use error, the instructions for use do contain the following caution: visually inspect the stapler to ensure proper cartridge seating.Position the tissue to be transected or resected in the jaws of the instrument.Push the retaining pin completely through the anvil and into the distal jaw of the instrument by using the retaining pin knob.This aligns the anvil and cartridge housing to provide the correct staple formation and also prevents compressed tissue from slipping from the jaws.Inspect for the unwanted presence of clips, instruments, or other hard objects between the surfaces of the anvil and the staple cartridge (reload).Closing or firing over these items can damage the instrument and result in poor staple formation.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 r57l91, 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: 16121299
• Report Number: 3005075853-2023-00148
• Device Sequence Number: 8558316
• Product Code: GDW
• UDI-Device Identifier: 10705036013235
• UDI-Public: 10705036013235
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 01/09/2023

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: 02/28/2023
• Device Model Number: TLH60
• Device Catalogue Number: TLH60
• Device Lot Number: R4077U
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown