• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA 2.5.8
Device Problem Data Problem (3196)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2014
Event Type  malfunction  
Manufacturer Narrative
The device (b)(4) has been inspected for investigation purpose. The tests performed confirmed that a design deficiency caused the software failure. (b)(4).
 
Event Description
Before the surgery, it has been reported that a software failure has been detected. The patient data file was not accessible. A surgery delay has been reported < 5 minutes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
7414400
MDR Report Key6423806
MDR Text Key70631271
Report Number3009185973-2017-00045
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,health
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 03/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA 2.5.8
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 Received06/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-