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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problems Overfill (2404); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Udi: (b)(4). 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
It was reported that preoperatively to a rotator cuff repair procedure on (b)(6) 2020, it was observed that saline kept filling past the line and was overflowing on the pump/shaver device. According to the report, the event occurred when the inflow pump tubing was turned on and the bags were spiked before the surgery. It was further reported that the cpc inducer was not reading anything and then a piece got stuck in it. We removed it and swapped the tubing but it still wasn¿t working. The pumps were switch ed. There was no delay. There were no adverse patient consequences reported. No additional information was provided.
 
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Brand NameFMS VUE PUMP-SHAVER BOX
Type of DeviceDISTENSION 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 Key10830419
MDR Text Key215976857
Report Number1221934-2020-03445
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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