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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 OPTICAL DISTANCE SENSOR
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 08/26/2019
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.(b)(4).
 
Event Description
The company field service engineer was called and notified that the distance sensor was not staying on while trying to perform registration during case.Surgeon was unable to get distance sensor to remain powered on, would lose connection during registration, and needed to restart registration.Surgeon checked connections in cable and to robot arm as instructed by fse, but loose connection appeared to be in cable itself.Case was neuropace, rosa use was abandoned, and proceeded with brainlab navigation.Delay of 30 minutes.No incision made.
 
Manufacturer Narrative
Dhr review did not identify any contributory factors to the event.Review of complaint history showed that two similar complaint were received for this device.A full analysis of the data logs has been performed and concluded that the origin of the shutdown of the distance sensor during the pre-registration was determined to be a hardware issue.The hardware problem could be related to a wiring issue.However, since this complaint, no new event was reported (one year without any reported issue: (b)(6) 2019 to (b)(6) 2020).This issue will still be monitored.
 
Event Description
The company field service engineer was called and notified that the distance sensor was not staying on while trying to perform registration during case.Surgeon was unable to get distance sensor to remain powered on, would lose connection during registration, and needed to restart registration.Surgeon checked connections in cable and to robot arm as instructed by fse, but loose connection appeared to be in cable itself.Case was neuropace, rosa use was abandoned, and proceeded with brainlab navigation.Delay of 30 minutes.No incision made.
 
Event Description
The company field service engineer was called and notified that the distance sensor was not staying on while trying to perform registration during case.Surgeon was unable to get distance sensor to remain powered on, would lose connection during registration, and needed to restart registration.Surgeon checked connections in cable and to robot arm as instructed by fse, but loose connection appeared to be in cable itself.Case was neuropace, rosa use was abandoned, and proceeded with brainlab navigation.Delay of 30 minutes.No incision made.
 
Manufacturer Narrative
Optical distance sensor was returned at manufacturing site on (b)(6) 2020 along with its laser offset plate s/n (b)(6) and the screws s/n (b)(6).After analysis of the returned product, it was determined that the conclusions of the initial investigation are confirmed.
 
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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 Key9115742
MDR Text Key165023159
Report Number3009185973-2019-00326
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,Followup
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOPTICAL DISTANCE SENSOR
Device Catalogue NumberROSAS00316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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