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

Catalog Number C-VH-4030

Device Problems Device Operates Differently Than Expected (2913); Electrical Shorting (2926)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number 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 during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable customer mentioned that the cable had a short in it and would not work properly.Another hp2 extension cable was opened to complete case.

Manufacturer Narrative

(b)(4).A serial/lot number was not provided and the specific product serial/lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable customer mentioned that the cable had a short in it and would not work properly.Another hp2 extension cable was opened to complete case.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7401662
• MDR Text Key: 104701115
• Report Number: 2242352-2018-00302
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

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 Catalogue Number: C-VH-4030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1