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

Catalog Number	TCT75
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r58v3r.Device evaluation: the analysis results found that the tct75 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 device fired and cut without any difficulties, the staple line was complete, the cut line was complete and the staples were noted to have the proper b-formed shape.The event described could not be confirmed as the device performed without any difficulties noted.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during a lobectomy, that the staples did not form properly, they were sticking straight up.Case completed with another device of the same product code.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7776932
• Report Number: 3005075853-2018-12050
• Device Sequence Number: 19441565
• Product Code: GDW
• UDI-Device Identifier: 20705036013157
• UDI-Public: 20705036013157
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/18/2018

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: 05/31/2023
• Device Catalogue Number: TCT75
• Device Lot Number: R40K1Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1