MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLE, IMPLANTABLE

Model Number	TA6035L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	03/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an exploratory small bowel resection procedure, while transecting the small bowel, the surgeon was able to completely squeeze the handle and the handle return to the open position following the first full squeeze of the handle.It also remain in the closed position following the second complete squeeze, but it did not fire.This happened using two reloads which caused tissue damaged.Bowel section 3-5 inch section was unusable and had to use a different section of bowel.Another resection was done and this time manual stapler was used to complete the procedure.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 8493155
• Report Number: 2647580-2019-01886
• Device Sequence Number: 13899159
• Product Code: GDW
• UDI-Device Identifier: 10884521043206
• UDI-Public: 10884521043206
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: TA6035L
• Device Catalogue Number: TA6035L
• Device Lot Number: P4M0744X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention