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

Model Number	TLC55
Medical Device Problem Codes	Failure to Cut (2587); Failure to Fire (2610)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
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 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.Could you please clarify if there were any patient consequences? could you please clarify if was any change in the post-operative care of the patient as a result of the event? 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 the stapler didn't staple and the knife tared the tissue.
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the tlc55 device was received with no apparent damage, with no reload present.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 there is no direct evidence of use error, 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.The event described could not be confirmed as the device performed without any difficulties and no cartridge was returned for analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/11/2020.Additional information was requested, and the following was obtained: 1.Could you please clarify if there were any patient consequences? no consequences on the patient.2.Could you please clarify if was any change in the post-operative care of the patient as a result of the event? no change.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10678790
• Report Number: 3005075853-2020-05314
• Device Sequence Number: 11565453
• 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,Followup
• Report Date (Section B): 09/28/2020

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: 05/28/2023
• Device Model Number: TLC55
• Device Catalogue Number: TLC55
• Device Lot Number: R40M56
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 11/11/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/11/2020; 12/07/2020
• Patient Sequence Number: 1