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

Catalog Number C-VH-4000

Device Problems Bent (1059); Failure to Advance (2524)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro 2.Tech set up system and he slid the hp2 shaft in the tool port, he forced and bent the black shaft.When attempted to use the jaws he was unable to advance the shaft and jaws.A replacement device was used to complete the procedure.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure using vasoview hemopro 2.Tech set up system and he slid the hp2 shaft in the tool port, he forced and bent the black shaft.When attempted to use the jaws he was unable to advance the shaft and jaws.A replacement device was used to complete the procedure.No patient involvement.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 25133344, 25134327, 25134370.The last 3 lots shipped to the account prior to the event date.There were no ncmr¿s for the reported lot number.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7627522
• MDR Text Key: 112292801
• Report Number: 2242352-2018-00572
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1