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

Model Number 284002

Device Problem Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

Synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Unable to confirm if the device was received, if received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.Udi:(b)(4).

Event Description

It was reported per the sales pep via phone that during a knee scope, the surgeon reported that they were unable to get any suction from the fms vue pump.They were able to complete the case with the same device.There was a 30 minute delay but there was no harm to the patient.This is all the information the sales rep has at this time.This complaint is for one (1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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.Corrected data: device listed as returned on 9/26/19.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.

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary the device was received and evaluated at the service center.The reported complaint that the device had suction issue was confirmed.The pinch valve was found to be defective upon evaluation.The defective pinch valve was replaced and the device was tested and found to be working according to specifications.The defective pinch valve is responsible for the suction issue reported by the customer.A manufacturing record evaluation was performed for the finished device (serial number : (b)(6)), and no non-conformances 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 a manufacturing record evaluation was performed for the finished device (serial number : (b)(6)), and no non-conformances were identified.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.

• Brand Name: FMS VUE FLUID MANAGEMENT SYSTEM
• 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: 9188273
• MDR Text Key: 208384255
• Report Number: 1221934-2019-58963
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020591
• UDI-Public: (01)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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284002
• Device Catalogue Number: 284002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Date Manufacturer Received: 11/06/2019
• Patient Sequence Number: 1