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

Model Number HEMOPRO2 EXTENSION CABLE

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2020

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.Device discarded.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable was not working properly (electrical signal was weak almost non detectable) as per the technicians testing.It was taken to hospital to be provided as a loaner for a hospital undergoing a trail.The cord was inspected by biomed before it could be used at their facility.No patient involvement.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, hemopro2 extension cable was not working properly (electrical signal was weak almost non detectable) as per the technicians testing.It was taken to hospital to be provided as a loaner for a hospital undergoing a trail.The cord was inspected by biomed before it could be used at their facility.No patient involvement.

Manufacturer Narrative

Internal complaint number: (b)(4).The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(4).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11031879
• MDR Text Key: 222330569
• Report Number: 2242352-2020-01140
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700925
• UDI-Public: 00607567700925
• Combination Product (y/n): N
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: HEMOPRO2 EXTENSION CABLE
• Device Catalogue Number: C-VH-4030
• Device Lot Number: 1845-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1