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 12/23/2021

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 an endoscopic vein harvesting procedure using t.W.Power supply.They stated that there is no energy output coming out of the disposable hand piece.When they switch to another power supply unit they were able to continue with the vein harvest.This issue happen twice on two different procedures with the same power unit.No injury reported.

Manufacturer Narrative

Trackwise # (b)(4).Corrected sections: h3 - h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun".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: g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the reported serial number.The vendor certifies that this device serial 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 dec 2019 through nov 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.Testing of actual/suspected device: (10 & 4105/13/22) the device was returned to the factory for evaluation on 01/19/2022.An investigation was conducted on 02/01/2022.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 reference power cord was attached to the power supply and the device was switched on.No green light was observed to indicate that there was power to the device.No other electrical testing was done due to no electrical power to the device.Based on the returned condition of the device, the reported failure "failure to deliver energy" was confirmed.

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: 13252906
• MDR Text Key: 284712168
• Report Number: 2242352-2022-00061
• Device Sequence Number: 1
• Product Code: HQO
• UDI-Device Identifier: 00607567700826
• UDI-Public: 00607567700826
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2022

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: 01/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/19/2022; 02/14/2022
• Supplement Dates FDA Received: 02/02/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1