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

Model Number	TCT75
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t5e45a.Additional information received from the surgeon: the stapler was put together and staples were deployed and cutter extended all the way, however after opening stapler the last 1-2 cm of staples were all mangled with sharp ends of staples sticking out.It appeared that maybe the cutter had somehow run through the staples.I resected this part of the staple line and over-sewed end of staple line.We opened a new stapler afterwards to complete anastomosis.Device analysis: the analysis results found that the tct75 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.The event described could not be confirmed as no malformed staples were observed and the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 during an unknown procedure the staple closure was incomplete.A second like device was used to complete the procedure with no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10137845
• Report Number: 3005075853-2020-02956
• Device Sequence Number: 14017209
• Product Code: GDW
• UDI-Device Identifier: 10705036013150
• UDI-Public: 10705036013150
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

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: 09/30/2024
• Device Model Number: TCT75
• Device Catalogue Number: TCT75
• Device Lot Number: T4101F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Patient Sequence Number: 1