MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW 7XB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VH-3200

Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Tw 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, vh-3200 vasoview 7xb would not activate and they tried changing the power supply (bovie).They reported no energy.Another bovie was tried with no success.The handpiece was switched out and the case was completed successfully.This incident caused a delay in the evh time.No harm.

Manufacturer Narrative

Tw id#(b)(4).Updated sections: b4, d10, g4, g7, h2, h3, h6, h10, h11.Corrected sections: h6--medical device ¿ problem code corrected from "1198" to "1211" the device was returned to the factory for evaluation on 10/23/2023.An investigation was conducted on 10/25/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed on the device.The blade and bisectors were observed to be intact with no visual defects.The blue toggle was able to be manipulated to retract and extend the cutter blade.The device was evaluated for electrical function.A pre-cautery test was performed and repeated 10 times over a 10 minute period according to the procedure in the instructions for use ((b)(6)).The device passed the pre-cautery test with a reference generator (recommended setting at 18) and reference bipolar cord.An activation test was performed and the device activated repeatedly with no failure observed.The bipolar cord connection was manipulated during activation.The device remained active and no sparks was observed.The device produced steam and the saline was observed to ¿boil¿ on the test gauze each time and no sparks were observed.Based on the returned condition of the device as well as the evaluation results, the reported failure "failure to deliver energy" was not confirmed.A lot history record review was completed for lots 3000322016, 3000321141, 3000319505, the last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the last 3 lots shipped to the account.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: VASOVIEW 7XB
• 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: 17978053
• MDR Text Key: 326195227
• Report Number: 2242352-2023-00886
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700369
• UDI-Public: 00607567700369
• Combination Product (y/n): N
• PMA/PMN Number: K041981
• 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: 01/08/2024

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: VH-3200
• Device Catalogue Number: VH-3200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/20/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOVIE MACHINE