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

Catalog Number C-VH-4020

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/07/2018

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 an endoscopic vein harvesting procedure, hemopro2 adaptor had electrical continuity challenges per customer.User replaced adapter and issue was resolved.Not clear what caused issue within adapter.The hospital did not report any patient effects.

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 an endoscopic vein harvesting procedure, hemopro2 adaptor had electrical continuity challenges per customer.User replaced adapter and issue was resolved.Not clear what caused issue within adapter.The hospital did not report any patient effects.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 adaptor had electrical continuity challenges per customer.User replaced adapter and issue was resolved.Not clear what caused issue within adapter.The hospital did not report any patient effects.

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.

• Brand Name: HEMOPRO2 ADAPTOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7545545
• MDR Text Key: 109513567
• Report Number: 2242352-2018-00497
• 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: 05/24/2018

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-4020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1