MAUDE Adverse Event Report: MAQUET CV T.W. POWER SUPPLY; UNIT, CAUTERY, THERMAL, AC-POWERED

Catalog Number C-VH-3010

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).Autonumber # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was making a different sound and was not cutting as usually does.

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was making a different sound and was not cutting as usually does.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood was observed.Knob is intact and can be turned with ease.Switch and receptacles for power cord and tool devices are clear from debris.No signs of cracks or damage.The device was evaluated for its electrical function according to the service manual (mcv00009931) section d- ¿functional tests¿ using a precision multi-meter and a 0.62ohm resistor hemopro power supply test box.The test box uses the 10k ohm resistor that is built into the hemopro cable.The device passed all tests.The green light indicator on the power supply turned on and the beeping tone was audible.No "different" sound can be heard while the device was tested.No electrical failure was observed.Adequate energy was delivered.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device serial number conforms to all applicable product specifications and requirements.Based on the returned condition of the device and the investigation results, the reported failure mode "electrical issue" was not confirmed.

Manufacturer Narrative

Corrected section: event or product problem: power supply s/n changed to (b)(4).(b)(4).

Event Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) was making a different sound and was not cutting as usually does.

• Brand Name: T.W. POWER SUPPLY
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7429901
• MDR Text Key: 105642718
• Report Number: 2242352-2018-00333
• Device Sequence Number: 0
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K043155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-3010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 05/29/2018; 06/14/2018
• Supplement Dates FDA Received: 06/01/2018; 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1