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

Lot Number 25161189

Device Problem Defective Device (2588)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

During the endoscopic vein harvest on the left arm the cautery was not working.A new device was opened with a new cord but it still did not work.A new cautery box was brought in but the cautery still did not work.An additional vasoview device was opened with a new cord and again it did not work.Another cautery box was brought in but it still did not work.The device was rep was called and an additional cord was opened and the device work.The wasted vasoview devices were wrapped up to give to the device rep.New cords have also replaced the faulty cords.Fda safety report ids# (b)(4).

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; wayne NJ
• MDR Report Key: 13206082
• MDR Text Key: 283671000
• Report Number: MW5106532
• Device Sequence Number: 2
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/09/2023
• Device Lot Number: 25161189
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White