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

Model Number	TA30V3L
Medical Device Problem Codes	Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on an open hemi-hepatectomy, during the occlusion of the hepatic veins, there was poor staple formation.The staples were not in the normal b-shape.The veins were immediately clamped and over sewed.The retaining pin did not get back after opening the instrument at the opening knob.The malformed staples also fell into the patient¿s cavity and were retrieved with forceps.The same issue occurred with 2 more reloads.

• 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: 12292260
• Report Number: 2647580-2021-02652
• Device Sequence Number: 17052910
• Product Code: GDW
• UDI-Device Identifier: 10884521043152
• UDI-Public: 10884521043152
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2021

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: 01/31/2026
• Device Model Number: TA30V3L
• Device Catalogue Number: TA30V3L
• Device Lot Number: P1B1523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/08/2021
• 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