MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284004

Device Problem Device Alarm System (1012)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device returned.Investigation summary the device was received and evaluated at the service center.Neither the fault reported by the customer could be verified nor another fault was found with the device during evaluation.The device was cleaned, repaired and tested for functionality.Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot a manufacturing record evaluation was performed for the finished device serial number (b)(4), and results obtained as follows: anomalies or discrepancies (non-conformance) : deviation (b)(4) as an response to co (b)(4).Udi: (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate via email that during the surgery the handpiece started to jitter and the fms vue ii pump started to beep to the error message that was displayed on the screen of the pump.The handpiece stopped responding and the foot pedal had to be connected but error and the noise continued.An alternative shaver hp and console had to be used to complete the surgery.No patient consequences were reported, however there was a surgical delayed of about 20 minutes.No additional information was provided.This report is 1 of 1 for (b)(4).

• Brand Name: FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): FMS
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9084269
• MDR Text Key: 196398019
• Report Number: 1221934-2019-58389
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705027934
• UDI-Public: (01)10886705027934
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K171237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284004
• Device Catalogue Number: 284004
• Device Lot Number: J13A70364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1