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

Model Number	SIGSDS30CTV
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fired a vascular staple load on this patient, and at the end of the staple line it bled.When inspecting the load it appears the staples did not fire and were stuck in the load.Dr.Proceeded to use another vascular staple on a different vessel on the patient.The load fired but this time the section on the inner part did not fire correctly and left staples in the load.This caused bleeding on the pt whom lost about 200mls from it.

• Brand Name: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 22728232
• Report Number: 22728232
• Device Sequence Number: 18389791
• Product Code: GDW
• UDI-Device Identifier: 10884521741874
• UDI-Public: (01)10884521741874(17)280430(10)N5E1844Y(20)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2025
• Report Date (Section F): 07/28/2025

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 Model Number: SIGSDS30CTV
• Device Lot Number: N5E1844Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Date Report Sent to FDA: 07/28/2025