MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2021

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 reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.Hemopro cautery intermittently cutout.After harvester transitioned from taking endo radial to taking gsv, they states that the hemopro cautery started to intermittently cutout power.They had the nurse replace the power supply with a new loaner.The problem continued so they struggled through the rest of the case without trying a different cord or kit.No patient harm.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro 2.Hemopro cautery intermittently cutout.After harvester transitioned from taking endo radial to taking gsv, they states that the hemopro cautery started to intermittently cutout power.They had the nurse replace the power supply with a new loaner.The problem continued so they struggled through the rest of the case without trying a different cord or kit.No patient harm.

Manufacturer Narrative

H3 correction: device discarded has been changed to device not returned.Internal complaint number: (b)(4).A lot history record review was completed for lots 25153426, 25154845, and 25155932 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.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11379273
• MDR Text Key: 233550243
• Report Number: 2242352-2021-00188
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1