MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC EVH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VASOVIEWHEMPRO (US) VH-3000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional 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 was discarded.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, customer mentioned a general issue with difficulty advancing the cutting tool within the harvesting cannula.Specifically they mentioned that it is often times very difficult to advance it during a vessel harvest and they had issues with small branch evulsion.
Additional Manufacturer Narrative
Updated sections: g4, g7, h2, h6, h10.Corrected sections: h3 changed to device not returned.Trackwise # (b)(4).A lot history record review was completed for lots 25149022, 25148770 and 25148575 the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.H3 other text : device not returned.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro (us) vh-3000, customer mentioned a general issue with difficulty advancing the cutting tool within the harvesting cannula.Specifically they mentioned that it is often times very difficult to advance it during a vessel harvest and they had issues with small branch evulsion.

• Brand Name: EVH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10347265
• Report Number: 2242352-2020-00660
• Device Sequence Number: 3398951
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: 00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/30/2020

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 Model Number: VASOVIEWHEMPRO (US) VH-3000
• Device Catalogue Number: VH-3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1