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 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

Related to (b)(4).The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) not working properly when connected to the hand piece.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) not working properly when connected to the hand piece.They completed the cases by swapping out power supply (vh 3010).They did state that there were no adverse effects to patients.

Manufacturer Narrative

E1 correction: event site address changed to "(b)(6)".Internal complaint number: (b)(4).Analysis of production: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the reported lot number.The vendor certifies that this device serial/lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaint was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period aug 2019 through jul 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Device not returned: (4114/3221/67) despite request and/or customer indication that the device would be returned; however, no device was returned.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• MDR Report Key: 12249261
• MDR Text Key: 264342407
• Report Number: 2242352-2021-00622
• 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: 08/05/2021

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 Expiration Date: 10/28/2011
• Device Model Number: T.W. POWER SUPPLY
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1