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

Model Number 284004

Device Problem Increase in Pressure (1491)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the pressure issue was found.Per service reports, this complaint can be confirmed.It was found during evaluation that the pressure were out of range.The y tube assembly were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The defective y tube assembly might be the most probable root cause for the pressure out of range.However, given the information provided, we cannot discern a definitive root cause for the same.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 10/30/2020 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.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.

Event Description

It was reported by the affiliate in (b)(6) that during equipment diagnostic testing, it was determined that there was an issued with the pressure on the fms vue pump-shaver box device.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: FMS VUE PUMP-SHAVER BOX
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11505247
• MDR Text Key: 242684620
• Report Number: 1221934-2021-00863
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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: 03/11/2021
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1