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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

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MEDOS INTERNATIONAL SàRL INFLOW TUBING FMS VUE 24PK SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Model Number 284508
Device Problem Overfill (2404)
Patient Problem Not Applicable (3189)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Udi: (b)(4).
 
Event Description
It was reported by the affiliate that during an arthroscopic rotator cuff repair when the remote control (fms vue/nextra) was connected to a unit preoperatively, it beeped and the error code fc014 was shown in the display, when the remote control was disconnected it stopped beeping. Then again it was reconnected to the unit and the beeping recurred. The remote control (fms vue/nextra) was not used in the procedure. The fluid volume in the chamber of the inflow tubing fms vue 24pk kept increasing up to the maximum level, then the pumping stopped working. The clamp connecting the irrigated fluid was closed, but the fluid did not decreased, they had to use a second intermediary tubeset 24pk but the same issue occurred an hour later and the water did not flow, even thought the error code was not shown on the display, the unit beeped and than the irrigation stopped working. They kept using the unit with a replacing arthrex pump, the shaver without the outflow tubing, and a replacing suction tubing. There was no patient consequence, however there was a surgical delay for less than 30 minutes. No additional information was provided.
 
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Brand NameINFLOW TUBING FMS VUE 24PK
Type of DeviceSURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9668212
MDR Text Key203537279
Report Number1221934-2020-00489
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/30/2021
Device Model Number284508
Device Catalogue Number284508
Device Lot Number5986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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