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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 Computer Software Problem (1112)
Patient Problem No Code Available (3191)
Event Date 12/11/2017
Event Type  Injury  
Manufacturer Narrative
Following the investigation, the root cause is linked to a design deficiency, the analysis concluded that controller detected an excessive error. However the cause of the excessive error cannot be determined.
 
Manufacturer Narrative
The investigation did not confim a design deficiency. The technical analysis concluded that the event is due to an excessive error detected by the mitsubishi controller and the reason why the controller detected this error remains unknown.
 
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose. Once the evaluation will be performed, a follow-up medwatch report will be submitted. No code available' was selected as the surgery was cancelled.
 
Event Description
It was reported that the surgeon attempted to start the device, but the robot arm would turn on audibly and then shutdown as it approached the patient. The surgery was cancelled.
 
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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
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key7132875
MDR Text Key132263715
Report Number3009185973-2017-00829
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
PK101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA 2.5.8
Device Catalogue NumberN/A
Device Lot Number2.5.8.4
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/26/2014
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

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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