MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT

Model Number N/A

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that, outside of surgery on (b)(6) 2023, the unit has no power.It was confirmed that the power inlet module fuse was burnt.There was no patient involved, nor impact to patient and/ or user.Due diligence information complete.No additional information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation are in process.Once the investigation is complete, a supplemental report will be filed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the unit was confirmed to not power on.One of the power inlet module fuses was found to be burnt.The power inlet module was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a poor connection at the fuse spring terminal-to-fuse is the root cause for the fuse drawer thermal issues during use.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Upon review of our reporting decision on blown fuses exhibiting signs of overheating.A review of all complaints for this product indicates that there has never been an event that has resulted in a death, serious injury, and/or actual fire when the fuse has blown or fuse drawer deformation.Therefore, zimmer biomet will not be reporting this failure mode going forward.

Event Description

No adverse events were reported as a result of this malfunction.No additional event information available.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
• Type of Device: SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17341633
• MDR Text Key: 319196776
• Report Number: 0001954182-2023-00081
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024501638
• UDI-Public: (01)00889024501638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• 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: 00514010400
• Device Lot Number: 46482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose