MAUDE Adverse Event Report: MAQUET CV VASO VIEW HEMOPRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number C-VH-3000

Device Problems Smoking (1585); Device Operates Differently Than Expected (2913)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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, vasoview hempro operator noted power source chime remained on when trigger was in neutral position.Device was removed from leg and unplugged.When plugged back in, smoke noted with trigger activation.Advised not to use any further and new device was opened to finish procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the harvesting handle.Slight amounts of charred material was observed on the heating wire.A microscopic inspection was conducted.The heater wire was observed to be slightly flexed away at the center of the hot jaw and remained attached at the tip and base of the hot jaw.No other visual defects were observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it produced visible steam during several activations over a period of 10 minutes and shut off when the toggle was released.The pre-cautery test was repeated 10 times with no observed failure.The handle was opened to evaluate the internal components.No visible defects were observed to the toggle, or the switch.The switch was examined under the microscope.No residue or contamination was seen on the switch.We were unable to observe any electrical issues.Based on the condition of the device as returned and the results of the evaluation, the reported failure ¿device remains activated¿ is not confirmed, however the analyzed failure "bent wire" is confirmed.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hempro operator noted power source chime remained on when trigger was in neutral position.Device was removed from leg and unplugged.When plugged back in, smoke noted with trigger activation.Advised not to use any further and new device was opened to finish procedure.The hospital did not report any patient effects.

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7438560
• MDR Text Key: 105891117
• Report Number: 2242352-2018-00350
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K052274
• 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: 04/17/2018

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 Expiration Date: 02/08/2019
• Device Catalogue Number: C-VH-3000
• Device Lot Number: 25137082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1