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

Catalog Number 284002

Device Problems Intermittent Continuity (1121); Overfill (2404); Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

(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 the sales rep via phone that over the past two weeks that when the black dial on the fms vue pump was turned a loud noise occurred.It was also discovered that the chamber fills to the top and there is no output of water which caused an unclear picture.While performing a knee scope today, the pump stopped working completely.There was a 10 minute delay as they switched out to use another like device and there was no patient harm.That is all the information the sales rep has at this time.

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary: the complaint device was received at the service center and evaluated.Per service manual operational and diagnostic, this complaint can be confirmed.During evaluation, the handle/lever was found to be loose and worn gear was identified.The handle/lever was re-seated/adjusted and the worn gear was replaced to resolve the issue.After repair, the device was found to be working according to the specifications.The loose handle/lever and the worn gear are the possible root cause of the reported problem, however, with the available information a definite root cause 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 04/20/2018 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.(b)(4).

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Brand Name: FMS VUE PUMP
• 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: 9169029
• MDR Text Key: 206780473
• Report Number: 1221934-2019-58863
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: 10886705020591
• Combination Product (y/n): N
• PMA/PMN Number: K130169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 10/29/2019; 10/30/2019
• Supplement Dates FDA Received: 10/30/2019; 11/01/2019
• Patient Sequence Number: 1