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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE
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MEDTECH SA ROSA BRAIN; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA BRAIN
Device Problem Unintended Collision (1429)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
Udi# : (b)(4).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
Surgeon called field service engineer for assistance.During seeg procedure, surgeon had placed bolt.Surgeon reported that when moving away from bolt, rosa moved unexpectedly and received warning that collision had occurred.The field service engineer talked surgeon through procedure of restart and attempting to reconnect.When rosa was still unable to connect to arm, and communication error re-occurred, surgeon removed instrument holder and instrument adaptor from rosa arm, while maintaining sterile field.Surgeon was able to re-start and continue surgery.No obvious adverse issues for patient.
 
Manufacturer Narrative
It was reported that a collision was detected by the device and multiple communication failures occurred.Dhr review and review of complaint history did not identify any contributory factors to the event.According to technical investigation the root cause of the collision cannot be determined.The collision provoked a shutdown of the device, this is a normal behavior.The root cause of the second shutdown is a shared memory error between rosanna_brain and mario_win software.
 
Event Description
Surgeon called field service engineer for assistance.During seeg procedure, surgeon had placed bolt.Surgeon reported that when moving away from bolt, rosa moved unexpectedly and received warning that collision had occurred.The field service engineer talked surgeon through procedure of restart and attempting to reconnect.When rosa was still unable to connect to arm, and communication error re-occurred, surgeon removed instrument holder and instrument adaptor from rosa arm, while maintaining sterile field.Surgeon was able to re-start and continue surgery.No obvious adverse issues for patient.
 
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Brand Name
ROSA BRAIN
Type of Device
COMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR  34000
MDR Report Key8685866
MDR Text Key147603885
Report Number3009185973-2019-00206
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K172444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA BRAIN
Device Catalogue NumberN/A
Device Lot Number3.0.0.21
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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