MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problems False Reading From Device Non-Compliance (1228); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was initially reported that the cart was giving incorrect volume readings and was leaking out of the bottom.The unit was at the ambulatory center across the street from the main building.Additional information obtained on december 14, 2016 stated that there was no report of patient or user harm in the event; however there is no way to verify if the event did or did not occur during a surgical procedure at this time.

Manufacturer Narrative

This complaint is being reported by zimmer biomet as (b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated or corrected: 510k number: k081047; k123188; k133786.The ultra duo high fluid cart, : smoke evacuator was manufactured on 2 may 2013 and was 41 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.The device was noted to have not been previously repaired by zimmer biomet surgical.Steven m.Hyatt was contacted about the cart and dispatched a service technician to be at the site.On 1 december 2016, the technician arrived at the site and confirmed that the cart was reading the proper fluid level for one of the cylinders.The technician replaced a level sensor and then verified that the cart was functioning as intended.He then returned the cart to service without further incident.The device was tested, inspected, and repaired.The root cause could not be specifically determined since the service technician was unable to reproduce the reported event.The root cause of the cart reading the incorrect fluid level also could not be specifically determined, but was most likely due to a level sensor wearing down over the 41 months that the cart had been in service.Neither of the level sensors had been previously replaced and could have begun to malfunction such that they would begin to send erroneous signals to the cart.The cart could then interpret these signals as a different fluid level inside of the cylinder than what is actually present.When the customer would then attempt to use the cart, the incorrect fluid level would then cause the cart to not function as intended.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6175163
• MDR Text Key: 62802087
• Report Number: 0001954182-2016-00003
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: ULDU500SE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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