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

Model Number VASOVIEW HEMOPRO 2

Device Problem No Flow (2991)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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, vasoview hemopro 2 unable to insufflate the tunnel with co2.The pa noted that the btt port; the one way valve on the co2 inflow line was not depressing.As a result no co2 was able to flow into the tunnel.The case was completed by replacing the btt port.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 unable to insufflate the tunnel with co2.The pa noted that the btt port; the one way valve on the co2 inflow line was not depressing.As a result no co2 was able to flow into the tunnel.The case was completed by replacing the btt port.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: b5,g4,g7,h2,h3,h6,h10.Internal complaint number: (b)(4).A lot history record review was completed for lots 25153483, 25153798, and 25155417 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
• MDR Report Key: 11518645
• MDR Text Key: 241042828
• Report Number: 2242352-2021-00206
• 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: 03/18/2021

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: VASOVIEW HEMOPRO 2
• Device Catalogue Number: VH-4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/03/2021
• Patient Sequence Number: 1