MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL FMS VUE PUMP-SHAVER BOX; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284004

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Udi: (b)(4).

Event Description

It was reported by affiliate via email that the fms vue pump-shaver box is damaged, no further information was provided.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.Additional information listed on the work order provided by the affiliate reported the pump had a defect when pumping out.Additional information provided by the affiliate reported the alleged malfunction occurred during a knee arthroscopy and the case was completed with the same pump.No patient consequences, surgical intervention, or surgical delay were reported.Additional details could not be provided.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> the complaint device was received at the service center and evaluated.It was reported that the device had a defect when pumping out and sucking did not work at full power.During evaluation, neither the fault reported by the customer could be verified nor another fault was found, therefore this complaint cannot be confirmed.As the reported problem was not confirmed, a root cause for the issue that was experienced by the user cannot be determined.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 11/22/2018 and passed all functional testing before being returned to the customer.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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
=
> the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 11/22/2018 and passed all functional testing before being returned to the customer.

• Brand Name: FMS VUE PUMP-SHAVER BOX
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9878629
• MDR Text Key: 205308341
• Report Number: 1221934-2020-00976
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705027934
• UDI-Public: 10886705027934
• Combination Product (y/n): N
• PMA/PMN Number: K171237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284004
• Device Catalogue Number: 284004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 05/11/2020
• Patient Sequence Number: 1