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

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Device Unsafe to Use in Environment (2918); No Apparent Adverse Event (3189); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

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.Device not returned.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 has noise/interference experienced when using the bovie at the same time as activation of cautery on the hp.When using the hp you can hear the beeping going at a certain cadence and when the bovie is used by the surgeon the cadence changes ( speeds up) and the device seems to have interrupted functionality.Once the bovie stops the beeping returns to its normal cadence.

Manufacturer Narrative

Updated sections: g4, g7, h2, h3, h6, h10, h11 correct b5 to reflect the corrected updated information corrected sections: h6 - device code changed trackwise # (b)(4).A lot history record review was completed for lots 25151806, 25152379, and 25152907 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 and the reported failure.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro vh-3500 has noise/interference experienced when using the bovie at the same time as activation of cautery on the hp.When using the hp you can hear the beeping going at a certain cadence and when the bovie is used by the surgeon the cadence changes ( speeds up) and the device seems to have interrupted functionality.Once the bovie stops the beeping returns to its normal cadence.The hospital did not report any patient effects.This has nothing to do with the hp unit itself.

Manufacturer Narrative

Trackwise # (b)(4).

• Brand Name: VASOVIEWHEMPRO VH-3500
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 10788521
• MDR Text Key: 214759782
• Report Number: 2242352-2020-00961
• 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,Followup
• Report Date: 11/04/2021

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: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 11/04/2021
• Supplement Dates FDA Received: 12/31/2020; 11/04/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.