MAUDE Adverse Event Report: COVIDIEN LP TA; STAPLE, IMPLANTABLE

Model Number	TA30V3S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Two ta staplers with dst series technology did not function as expected.1.Lot # p5j1221, exp 08/31/2030.2.Lot # p5e1152, exp 04/30/2030.

• Brand Name: TA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 24828325
• Report Number: 24828325
• Device Sequence Number: 21440057
• Product Code: GDW
• UDI-Device Identifier: 10884521043145
• UDI-Public: (01)10884521043145
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 04/07/2026

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
• Device Model Number: TA30V3S
• Device Lot Number: P5J1221, P5E1152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 04/07/2026