MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 EXTENSION CABLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-4030

Device Problem Material Frayed (1262)

Patient Problem Electric Shock (2554)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint # trackwise # (b)(4).Autonumber # (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 post use of an endoscopic vein harvesting procedure, the user unplugged the cable and received a mild electrical shock.The hospital stated that the cable was frayed a little when cable was opened.There was no patient injury, and the user was not injured aside from the mild electrical shock.

Manufacturer Narrative

Internal complaint # trackwise #(b)(4).Autonumber # (b)(4).This is a reusable oem device; therefore, a lot history/serial number review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that post use of an endoscopic vein harvesting procedure, the user unplugged the cable and received a mild electrical shock.The hospital stated that the cable was frayed a little when cable was opened.There was no patient injury, and the user was not injured aside from the mild electrical shock.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8241966
• MDR Text Key: 132907899
• Report Number: 2242352-2019-00056
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4030
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention