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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 06/16/2015
Event Type  malfunction  
Manufacturer Narrative
Device ro14031 has been inspected for investigation purpose.The tests performed confirmed minor wear on bottom starbust teeth of the articulated arm exists.The defective component was replaced by a support arm.
 
Event Description
During maintenance performed at the customer site by a field engineer, it was observed that there was minor wear on the starburst teeth of the articulated arm.
 
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Brand Name
ROSA SURGICAL DEVICE
Type of Device
COMPUTER ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, 34000
FR  34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, 34000
FR   34000
Manufacturer Contact
jay sharma
zac eureka
900 rue du mas de verchant
montpellier, 34000
FR   34000
7414400
MDR Report Key6463873
MDR Text Key71897540
Report Number3009185973-2017-00431
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 Replace
Type of Report Initial
Report Date 04/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberROSA 2.5.8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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