MAUDE Adverse Event Report: 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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

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 preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was not delivering energy to hemopro.Alternate power supply was brought in and it fixed the problem.Power supply is out of warranty.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) was not delivering energy to hemopro.Alternate power supply was brought in and it fixed the problem.Power supply is out of warranty.No patient involvement.

Manufacturer Narrative

(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 lot 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
• MDR Report Key: 11515215
• MDR Text Key: 240622616
• Report Number: 2242352-2021-00199
• 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: 03/15/2021

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
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/06/2021
• Patient Sequence Number: 1