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 Hemorrhage/Bleeding (1888)

Event Date 04/28/2022

Event Type  Injury  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using hemopro.They were harvesting vein and had finished dissection.They started with branch ligation, inserting the cannula/scope into the leg.Upon encountering the first branch, they attempted sealing and ligation, but the branch bled heavily.Since they had experienced this occurring in the past, they opted to change out the generator for a new one.This included changing out the adapter as well.The subsequent branches did not bleed as energy was applied and sealing/ligation occurred.The generator was set at 3 and confirmed.No injury to the patient.

Manufacturer Narrative

Trackwise (b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using hemopro.They were harvesting vein and had finished dissection.They started with branch ligation, inserting the cannula/scope into the leg.Upon encountering the first branch, they attempted sealing and ligation, but the branch bled heavily.No additional blood transfusions were required.No blood loss.The bleeding was controlled by applying manual pressure.Since they had experienced this occurring in the past, they opted to change out the generator for a new one.This included changing out the adapter as well.The subsequent branches did not bleed as energy was applied and sealing/ligation occurred.The generator was set at 3 and confirmed.There was no procedural delay.No injury to the patient.

Manufacturer Narrative

(b)(4).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.H3 other text : device not returned.

• 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: 14593855
• MDR Text Key: 293277408
• Report Number: 2242352-2022-00467
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention