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 07/21/2021

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

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) no longer turns on when plugged in.This was identified between cases so no patient was involved.

Event Description

N/a.

Manufacturer Narrative

Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) 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.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial 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 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.Testing of actual/suspected device & testing of raw/starting materials: (10 & 4105/213/67) enter investigation the device was returned to the factory on 27sep2021.An investigation was conducted on 13oct2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.No visual defects were observed.The device was connected to a power cord and the power switch was turned to the "on" position.The device was able to be energized.The green indicator light did illuminate and the device provided energy to a reference hemopro device and extension cable.An electrical evaluation was conducted.A pre-cautery test was performed per the direction for use (dfu) with a reference cable, adapter and the returned power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced visible steam and heat during ten (10) 3-second activations and shut off when the toggle was released.To evaluate the safety shut down system, a polyfuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after 10-second cooling period with no incident each time.A functional test was performed on the unit using the ¿vasoview power supply accuracy and power supply operating ranges¿ outlined in equipment calibration procedure for vasoview power supply, mcv00030545, rev b., section 7.1.2 accuracy - a) no load voltage test ¿ requirement: 5.5 vdc +/-.05 vdc step b) low current output test ¿ requirement: 4.0 +/-.05 amps dc step c ) high current output test¿ requirement: 6.0 +/-.05 amps dc.The device passed no load voltage test: 5.580 vdc (passed), the low current output test: 4.00 amps (passed) and high current output test: 6.00 amps (passed).Based on the returned condition of the device, the reported failure "failure to deliver energy" was not confirmed.

Event Description

N/a.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• MDR Report Key: 12300355
• MDR Text Key: 265790610
• Report Number: 2242352-2021-00659
• 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: 10/19/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 09/27/2021; 10/19/2021
• Supplement Dates FDA Received: 10/15/2021; 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2014
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1