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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL FMS VUE II PUMP-SHAVER BOX; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problems Moisture Damage (1405); Overfill (2404); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2022
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Initial reporter occupation: reporter is a j&j employee.Device manufacture date: the device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
This is report 2 of 3 for (b)(4).It was reported by the affiliate in japan that during an arthroscopic rotator cuff repair procedure on (b)(6) 2022, it was observed that the fluid volume in the chamber of the inflow tubing (284508) device kept increasing up over the maximum level.According to the report, the filter allowed fluid to pass through easily and directly into the pressure sensor connect port on the fms main unit (284004).It was reported that as the fluid had entered the inside of the fms device, a warning lit up on the display.It was reported that a new inflow tubing was replaced, which did not correct the issue either.It was reported that once they turned it off, it wouldn't turn on.It was reported that there was no response even after changing the power cord and changing the insertion point.It was reported that it was confirmed that the fuse inside was blown.It was reported that after replacing the fuse, it started but did not work properly.As a result, the shaver (283512) became unusable.Another like device was used to complete the procedure with less than 30 minutes delay.There was no harm to the patient.No additional information was provided.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the customer provided a photo of the pump, the image shows the front side and controls of the pump, the pump is not turned on and it is not set up with the tubbing.The complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: ¿functional : electrical/electronic component failure.Per service reports, this complaint can be confirmed.The defective parts needs to be replaced to resolve the issues.A manufacturing record evaluation was performed for the finished device j10a70319, and no non-conformances were identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts were identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.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.During the service evaluation the following defects were identified: functional : electrical/electronic component failure.Per service reports, this complaint can be confirmed.The circuit board, power supply were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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.
 
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Brand Name
FMS VUE II 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
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key15242967
MDR Text Key305465677
Report Number1221934-2022-02536
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705027934
UDI-Public10886705027934
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
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 Expiration Date04/10/2020
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/05/2022
Initial Date FDA Received08/17/2022
Supplement Dates Manufacturer Received09/06/2022
09/14/2022
09/30/2022
Supplement Dates FDA Received09/07/2022
09/16/2022
10/03/2022
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 Unknown
Patient Sequence Number1
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