MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Model Number T.W. POWER SUPPLY

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device not returned.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply stopped activating and releasing thermal energy.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply stopped activating and releasing thermal energy.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(6).The vendor certifies that this device serial conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10785801
• MDR Text Key: 214580286
• Report Number: 2242352-2020-00947
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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 Operator: Health Professional
• Device Model Number: T.W. POWER SUPPLY
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1