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	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: t5ed7w.(b)(4).Device analysis: the product was returned and 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 returned fully fired.The device was tested for functionality with a test reload 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.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: 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.As part of ethicon endo surgerys quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure the the stapler was used a couple of times successfully and the last load they tried to fire did not expel any staples.But the doctor said that it did cut.There were no poor outcomes due to this.The surgeon was able to finish the surgery.Sales rep was not in the case.No patient consequences were reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11194452
• Report Number: 3005075853-2021-00327
• Device Sequence Number: 19018272
• Product Code: GDW
• UDI-Device Identifier: 10705036013204
• UDI-Public: 10705036013204
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: 10/01/2024
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1