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

Catalog Number C-VH-4030

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable while harvester was in mid-harvest, the harvesting tool slowly stopped giving an effective amount of energy to properly ligate the vein.After a couple minutes of struggling, the harvesting tool lost heat completely when heat source was activated.Harvester disconnected cord from hemopro 2 harvesting tool and alternate cord and ample heat returned to harvesting tool.Case resumed as planned without any further issue.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot/serial history review was not applicable.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.The hemopro2 extension cable device was returned to the factory for evaluation.The device showed signs of clinical usage and no evidence of blood.A visual inspection was conducted.No defects were observed.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident.An electrical evaluation was performed.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2, reference adapter cable and reference power supply vh-3010 at level 3.0.The device did not passed the pre-cautery test; it intermittently produced steam and heat during 5-second activations and shut off when the toggle was release.A polyfuse electrical test was performed with the same reference power supply, adapter cable and hemopro 2; the polyfuse intermittently shut off power to the heater after 5-10 seconds of actuation periods.Based upon the evaluation results, the reported mode ¿failure to deliver energy¿ was not confirmed but was confirmed for analyzed failure mode ¿intermittent continuity".

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable while harvester was in mid-harvest, the harvesting tool slowly stopped giving an effective amount of energy to properly ligate the vein.After a couple minutes of struggling, the harvesting tool lost heat completely when heat source was activated.Harvester disconnected cord from hemopro 2 harvesting tool and alternate cord and ample heat returned to harvesting tool.Case resumed as planned without any further issue.The hospital did not report any patient effects.

• 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: 7448990
• MDR Text Key: 106651799
• Report Number: 2242352-2018-00366
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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