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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number OPTICAL DISTANCE SENSOR
Device Problem Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Date 12/22/2018
Event Type  malfunction  
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted. The device model rosa one is not fda cleared but is similar to the device rosa brain, classified haw and cleared under k172444. (b)(4).
 
Event Description
It was reported that the optical distance sensor failed and accuracy test performed part of a preventive maintenance.
 
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Brand NameROSA ONE
Type of DeviceCOMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key8264174
MDR Text Key134358333
Report Number3009185973-2019-00021
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberOPTICAL DISTANCE SENSOR
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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