MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*55MM LINEAR CUTTER; STAPLE, IMPLANTABLE

Model Number	TLC55
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.Is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.).
Event or Problem Description
It was reported that during an unknown procedure, "gap in staple line when firing.No further information available.
Additional Manufacturer Narrative
(b)(4).Date sent: 06/14/2021.D4: batch # u5d252.H6: component code = others (g07).Device analysis: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the tlc55 device was received with no apparent damage and with a reload loaded in the device.The reload was received unfired and with the swing tab in the unlocked position.The device was tested for functionality with the returned cartridge and it fired, cut, and formed all the staples as intended.The staple line and cut line were complete, and the staples meet the staple form release criteria.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: ensure that the tissue lies flat between the forks.Any ¿bunching¿ of tissue along the reload or scale may result in an incomplete staple line.Tissue to be transected must be located between the arrows marked on the instrument jaw.Any tissue located outside of the arrows is out of the stapling range.When positioning the stapler on the application site, ensure that no obstructions such as clips, stents, guide wires, etc., are within the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10971412
• Report Number: 3005075853-2020-06506
• Device Sequence Number: 14517641
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• Combination Product (Y/N): N
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 06/03/2025
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Device Lot Number: U40F2V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1