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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 Consequences Or Impact To Patient (2199)
Event Date 01/18/2017
Event Type  malfunction  
Manufacturer Narrative
User error during the tightening of the screw could be the root cause of the defect. If the two parts of the support arm rosa-256-e (se6 and se7) are not correctly aligned during installation. It is possible to damage the thread and the screw during tightening.
 
Event Description
At the beginning of the surgery, while installing the mayfield head holder adapter on the device surgeon found a lot of resistance from one of its screws. However surgeon was able to position this part appropriately to perform surgical procedure. At the end of the surgical procedure, the mayfield head holder adapter was disassembled and it was noticed that the screw and corresponding screw threads were damaged.
 
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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
elise lagacherie
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
467107740
MDR Report Key6352847
MDR Text Key130550828
Report Number3009185973-2017-00016
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
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
Type of Report Initial,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
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? No
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2015
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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