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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA 2.5.8
Device Problem Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 06/16/2014
Event Type  malfunction  
Manufacturer Narrative
The device (b)(4) has been inspected for investigation purpose. The tests performed confirmed that the hydraulic actuator system did not work properly. Hydraulic system was purged for repair purpose.
 
Event Description
During an intervention performed on customer site by our field engineer, it was identified that the hydraulic stabilisation system was non-functional. There was no patient involvment reported.
 
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Brand NameROSA SURGICAL DEVICE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
7414400
MDR Report Key6449628
MDR Text Key71470745
Report Number3009185973-2017-00363
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Repair
Type of Report Initial
Report Date 03/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA 2.5.8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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