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

Catalog Number C-VH-3010

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was not working, it was missing a knob and show signs of being dropped.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was not working, it was missing a knob and show signs of being dropped.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

Internal complaint #: trackwise #: (b)(4).Autonumber #: (b)(4).This is a reusable oem device; therefore, a lot history review/serial number review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.

• 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: 8603128
• MDR Text Key: 144806994
• Report Number: 2242352-2019-00555
• Device Sequence Number: 1
• Product Code: HQO
• 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: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1