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

Model Number	VH-3000
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Elective cab.Pa was performing endoscopic vein harvesting using vasoview hemopro #vh-3000, maquet lot #25144498, exp date: 2020-02-07, endoscopic vessel harvesting system.During process, scissor tip cracked/broke.It was removed from service and sent to rm.A new system was opened.Vasoview hemopro # vh -3000, maquet lot #2514464,9 exp date 2020-02-13 - again during harvest, the scissor tip broke - tip saved and taped to the instrument.Removed from service and sent to rm.Pt stable - no injuries noted.Pt to icu.

• Brand Name: VASOVIEW HEMOPRO
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8572995
• Report Number: 8572995
• Device Sequence Number: 243591
• Product Code: GEI
• UDI-Device Identifier: 00607567700345
• UDI-Public: (01)00607567700345
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/27/2019
• Report Date (Section F): 03/27/2019

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: VH-3000
• Device Catalogue Number: VH-3000
• Device Lot Number: 25144498
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 101
• Date Report Sent to FDA: 03/27/2019