MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO (US) VH-3000; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEWHEMPRO (US) VH-3000
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, smoke coming from jaws of instrument after device was taken out of the leg and energy wasn't being activated by the harvester.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
Additional Manufacturer Narrative
Trackwise # (b)(4).
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, smoke coming from jaws of instrument after device was taken out of the leg and energy wasn't being activated by the harvester.The hospital did not report any patient effects.

• Brand Name: VASOVIEWHEMPRO (US) VH-3000
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10406737
• Report Number: 2242352-2020-00713
• Device Sequence Number: 2403784
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25149711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1