MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC 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 05/16/2022

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure t.W.Power supply there wasn't any power going to the device.The power setting was at '3.The cord was changed.The adapter cable was changed.The vh-3010 was changed and that corrected the problem.There was no patient injury.

Manufacturer Narrative

Trackwise id (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: b4, e3, g4, g7, h2, h3, h6, h10.The device was returned to the factory for evaluation on 06/01/2022.An investigation was conducted on 06/09/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the power supply.An electrical evaluation was conducted.A cable and adaptor was returned.A reference power cord was attached to the power supply and the device was switched on.The green light was observed to indicate that there was power to the device.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a returned cable, adapter and 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 with no excessive smoke observed.A tone was audible from the power supply upon activation.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 pre-cautery test was also performed per the instruction for use (ifu) with a reference cable, adapter and 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 with no excessive smoke observed.A tone was audible from the power supply upon activation.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.Based on the returned condition of the device, the reported failure "failure to deliver energy " was not confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the serial # h10030208g.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

N/a.

• 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
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 14657279
• MDR Text Key: 295504871
• Report Number: 2242352-2022-00504
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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: 06/01/2022
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1