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

Model Number T.W. POWER SUPPLY

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (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 the beginning of an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was being used on an endo radial harvest when it started to intermittently cut out followed by stopping working completely.This occurred during the beginning of the case in which the harvester taking vein had to stop what he was doing so the radial artery could use his power unit (since the radial had its tourniquet up).This delayed the harvest of the vein but both were retrieved successfully.Biomed checked the unit subsequently and found that it was completely dead.They found that the device is past its 1 year warranty period so they plan to purchase a replacement.No patient harm.

Manufacturer Narrative

Trackwise # (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.

Event Description

The hospital reported that during the beginning of an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was being used on an endo radial harvest when it started to intermittently cut out followed by stopping working completely.This occurred during the beginning of the case in which the harvester taking vein had to stop what he was doing so the radial artery could use his power unit (since the radial had its tourniquet up).This delayed the harvest of the vein but both were retrieved successfully.Biomed checked the unit subsequently and found that it was completely dead.They found that the device is past its 1 year warranty period so they plan to purchase a replacement.No patient harm.

Manufacturer Narrative

Trackwise # (b)(4).

Event Description

The hospital reported that during the beginning of an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was being used on an endo radial harvest when it started to intermittently cut out followed by stopping working completely.This occurred during the beginning of the case in which the harvester taking vein had to stop what he was doing so the radial artery could use his power unit (since the radial had its tourniquet up).This delayed the harvest of the vein but both were retrieved successfully.Biomed checked the unit subsequently and found that it was completely dead.They found that the device is past its 1 year warranty period so they plan to purchase a replacement.No patient harm.

• 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: 11105676
• MDR Text Key: 224791890
• Report Number: 2242352-2021-00005
• 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,Followup
• Report Date: 12/29/2020

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: C-VH-3010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/03/2021
• Supplement Dates Manufacturer Received: 01/06/2021; 02/01/2021
• Supplement Dates FDA Received: 01/06/2021; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1