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

Model Number	TLC55
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t5cz0l.Device analysis: the analysis results found that the tlc55 device was received with no apparent damage and with a cartridge reload loaded on the device.The reload was received with 9 drivers up along staple line, and the swing tab in the unlocked position.The device was tested for functionality with a test reload and it fired, cut and formed all the staples as intended.The device fired without any difficulties, the staple line was complete, and the staples meet the staple form release criteria.It should also be noted that after the staple retainer has been removed, an inadvertent movement of the firing knob could cause the wedges to move forward and therefore cause the staples to become dislodged.Please reference the instruction for use for more information.It should be noted that all devices are inspected 100% for staple presence by an automated vision system and are visually inspected 100% as a final check.In addition, at finished goods the devices are visually inspected based on a sample.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, when unpacking the stapler, it looked like it was already fired.The staplers were not attached to the reload and was laying loose in the packaging.The surgery was delayed by 5-minutes.Replaced with same like device and the procedure was successfully completed.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 9653183
• Report Number: 3005075853-2020-00655
• Device Sequence Number: 2455953
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2019

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: 05/29/2024
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Device Lot Number: T40L8M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1