MAUDE Adverse Event Report: MAQUET GETINGE GROUP/MAQUET CARDIOVASCULAR, INC. VASOVIEW HEMOPRO ENDOSCOPIC HARVESTING SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATIONS & ACCESSORIES

Model Number VH 4000

Device Problems Crack (1135); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  malfunction  

Event Description

Pt was undergoing cabg x3 with saphenous vein usage.At the time the vasoview trocar was removed from the right leg, it was noted that the trocar was cracked and a small piece of the plastic was missing.The wound area was inspected and the missing piece was not able to be located, and assumed to be flushed out with wound irrigation.

• Brand Name: VASOVIEW HEMOPRO ENDOSCOPIC HARVESTING SYSTEM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATIONS & ACCESSORIES
• Manufacturer (Section D): MAQUET GETINGE GROUP/MAQUET CARDIOVASCULAR, INC. ; wayne NJ 07470
• MDR Report Key: 8982521
• MDR Text Key: 158638665
• Report Number: MW5089670
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: VH 4000
• Device Lot Number: 25147538
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR