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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA
Device Problems Computer Software Problem (1112); No Display/Image (1183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2019
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.
 
Event Description
It was reported that there were two device shutdowns during the surgery. Then, the touchscreen was not touch-sensitive anymore. The mouse was working.
 
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Brand NameROSA
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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key8408528
MDR Text Key138434078
Report Number3009185973-2019-00076
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA
Device Catalogue NumberN/A
Device Lot Number2.5.8.4
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 Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2015
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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