MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW VV6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-2400

Device Problem Failure to Deliver Energy (1211)

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

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

Tw 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.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro stopped working.There was no electrical energy to activate device.It was being used on fatty tissue.Power setting was 40 coag.A second device was used to complete the case.There was no harm to the patient or any delay reported.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 10/13/2023.An evaluation was conducted on 10/17/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The c-ring was observed to be intact with no visual defects.The blade and bipolar electrodes were observed to be intact with no visual defects.A mechanical evaluation was conducted.The toggle extended and retracted the blade.An electrical evaluation was performed.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use (cv000001597 rev.G).The device passed the pre-cautery test with a reference generator (recommended setting of 18) and reference bipolar cord.The bipolar cord connection was manipulated during activation.The device remained active and no intermittent continuity was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time.Based on the results of the evaluation, the reported failure "failure to deliver energy" was not confirmed.The lot # 3000332490 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOVIEW VV6 PRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 17974907
• MDR Text Key: 326133207
• Report Number: 2242352-2023-00882
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: 00607567700239
• Combination Product (y/n): N
• PMA/PMN Number: K091733
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000332490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 120 KG