MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.

Event Description

The hospital had a question about the design of the vh-3500 jaw, specifically regarding the exposed area at the tip.Is this area active when in use? does the exposed metal area of jaw activate while in use? please provide answer in response letter by december 10, 2020.No patient involvement.

Event Description

The hospital had a question about the design of the vh-3500 jaw, specifically regarding the exposed area at the tip.Is this area active when in use? does the exposed metal area of jaw activate while in use? please provide answer in response letter by december 10, 2020.No patient involvement.

Manufacturer Narrative

Trackwise #(b)(4).The device was not returned to maquet cardiac surgery for investigation, therefore no evaluation could be performed.It is not possible to confirm the reported complaint, however a photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The gray silicone insulation on both the cold and hot jaws was observed to be intact, no visual defects were observed.The heater wire was observed to be intact, no visual defects were observed on the heater wire.No specific failure mode was reported, therefore we are unable to confirm any failures based on the photographic inspection.A lot history record review was completed for lots 25150276, 25150426, and 25150561 the last 3 lots shipped to the account prior to the event/aware date.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.

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11049677
• MDR Text Key: 241254060
• Report Number: 2242352-2020-01143
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1