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

Model Number VH-3010

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure the t.W.Power supply "cautery" was not working.The staff troubleshot by switching out the hemopro power supply and adapter.The hemopro "cautery" worked normal and as intended.Clinician states it was not the hemopro device that was the problem.There was intermittent cautery at first then nothing after a couple minutes.Second generator worked fine.Minimal case delay for troubleshooting and had no effect on patient outcome.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).The device was returned to the factory for evaluation on 08/23/2023.Photographs were provided by the account.A photographic evaluation was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the device in the photograph.An investigation was conducted on 08/29/2023.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.The returned power cord was plugged into the device and the device was switched on.A pre-cautery test was performed per the instruction for use (ifu) with a reference adapter, vasoview hemopro 2 device, and the returned power cord and power supply vh-3010 at level 3.0.The device did passed the pre-cautery test.It did produce visible steam and heat during ten (10) 3-second activations.A tone was audible from the power supply upon activation.Based on the returned condition of the device as well as the evaluation results, the reported failure "electrical problem" was not confirmed.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.

Event Description

N/a.

• Brand Name: HEMOPRO 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: 17684546
• MDR Text Key: 322663306
• Report Number: 2242352-2023-00741
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-3010
• Device Catalogue Number: VH-3010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.