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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: 1.Could you please provide more details of ¿stapler misfired¿? staples ejected but did not engage tissue properly.2.Did the device cut? unsure 3.If the device cut, was the cut line complete? unsusre 4.Were the cut line and staple lines equal? unsure 5.Was the device fired across a staple line? unsure 6.Did the reload lock out and would not work? unsure 7.Did the reload begin to staple and cut, but then jammed? no 8.Did the device staple, but there was no cut line? yes, but staples did not fire appropriately.9.If the device cut and stapled, were there any staples missing from the staple line? unsure 10.If the device stapled, what was the shape of the staples (b-formation, irregular, legs straight)? unsure 11.How was the procedure completed? an additional 5cm of bowel was removed.Additional stapler opened and used.12.Could you please clarify if there were any patient consequences? yes, additional 5cm bowel removed.
Event or Problem Description
It was reported that there was a production malfunction.The stapler misfired and staples ejected but did not engage tissue properly.An additional five centimetres of tissue had to be removed.No additional information.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10043450
• Report Number: 3005075853-2020-02544
• Device Sequence Number: 11716412
• Product Code: GDW
• UDI-Device Identifier: 10705036013150
• UDI-Public: 10705036013150
• Combination Product (Y/N): N
• 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): 04/24/2020

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: 10/31/2024
• Device Model Number: TCT75
• Device Catalogue Number: TCT75
• Device Lot Number: T41268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/11/2020
• Patient Sequence Number: 1