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	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: month and day unknown.Only year (2020) is known.Batch #unk the lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during an unknown procedure, there were malformed staples at the proximal end of the staple line.Two blue reloads were used and the same issue occurred.A second like stapler was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 03/05/2020.D4: batch # r5ar8x.Device analysis: the analysis results found that the tlc55 device was received with no apparent damage and with two reloads present.The reloads (b & c) were 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.The event described could not be confirmed as no malformed staples were observed and the device performed without any difficulties noted.Reload b:tcr55, p57g7j fullyu fired.Reload c: tcr55, r5ar0a fullyu fired.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: 9674246
• Report Number: 3005075853-2020-00797
• Device Sequence Number: 2288754
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 10/15/2023
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROXIMATE CUTTER RELOAD UNIT.