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

Model Number	TA9048L
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/16/2021
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, on a laparoscopic partial gastrectomy which was converted into open due to the device issue, the stapler was used for the partial stomach resection, but the staple line was incomplete.The surgeon had to remove extra portion of stomach and re-staple with a linear stapler to fix the issue.The surgical time was extended by more than 30 minutes.

• 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: 12583594
• Report Number: 2647580-2021-03397
• Device Sequence Number: 3288526
• Product Code: GDW
• UDI-Device Identifier: 10884521043268
• UDI-Public: 10884521043268
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 05/31/2025
• Device Model Number: TA9048L
• Device Catalogue Number: TA9048L
• Device Lot Number: P0F0216MY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/06/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 64