MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; ULTRAFLEX¿ DUO #UL-DU500

Model Number N/A

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.

Event Description

It was initially reported that while in a case, when the account turned on suction, fluid sprayed all over staff through the shaver (attachment).On october 26, 2016, the repair technician tested vacuum on both cylinders, 600 mmhg at vacuum line and from manifold.No leaks during wash cycles.Verified unit functioning as intended.

Manufacturer Narrative

This report is being amended to reflect changes in report date, manufacturer site, type of reports, if follow-up, what type?, evaluation codes, and additional mfr narrative.Ultra duo flex fluid cart was manufactured on 11 april 2014 and was 25 months old at the time this complaint was generated.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm, the device was noted to have not been previously repaired by zimmer biomet surgical.On 25 october 2016, it was reported from (b)(6) that when the vacuum was turned on with a cart it sprayed fluid.(b)(4) was contacted about the cart and dispatched a service technician to be at the site the following day.On 26 october 2016, the technician arrived at the site and inspected the device.The technician verified that the cart was functioning as intended and then returned the cart to service without further incident.The device was tested and inspected.The root cause of the cart spraying fluid could not be specifically determined, since the service technician was unable to reproduce the reported event.The instructions for use for the ultra duo flex fluid cart state for the customer to only use dornoch-approved accessories.The duo cart would not have been designed to function with the adapteur power system ii (aps ii) shaver handpiece.The adapteur power system ii handpiece is capable of generating its own suction and if the customer would have rigged the shaver hand piece such that it would be attached to the manifold filter on the cart, the device could have been attached in a way such that it would generate sufficient suction to pull collected fluid inside of the cart through the manifold housing.The fluid could then have escaped the cart through the handpiece.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: ULTRAFLEX¿ DUO #UL-DU500
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: david bailey ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 6127100
• MDR Text Key: 61143039
• Report Number: 0001954182-2016-00002
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2016
• 2 Devices were Involved in the Event: 1 2

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 Model Number: N/A
• Device Catalogue Number: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1