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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE
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MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2020
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
Upon turning the robot stand on, the computer monitor would not turn on.The computer was confirmed to be on by the field service engineer (fse), taylor collins.The robot stand was powered on an off multiple times and the monitor still did not turn on.The back panel had to be removed from the monitor and the vga cable had to be re-seated.This incident caused about a ten minute delay to the case as the patient was already connected to the robot via the head holder.The patient was not harmed during this incident.
 
Event Description
Upon turning the robot stand on, the computer monitor would not turn on.The computer was confirmed to be on by the field service engineer (fse), taylor collins.The robot stand was powered on an off multiple times and the monitor still did not turn on.The back panel had to be removed from the monitor and the vga cable had to be re-seated.This incident caused about a ten minute delay to the case as the patient was already connected to the robot via the head holder.The patient was not harmed during this incident.
 
Manufacturer Narrative
It was reported that upon turning the robot stand on, the touchscreen would not turn on.The robot stand was powered on an off multiple times and the touchscreen still did not turn on.It appeared that the vga cable had to be re-plug.Photos of the vga cable and vga plug on the touchscreen were provided (refer to photos attached).It appears that the vga plug and the vga connector are damaged.Moreover, the field service engineer stated that one screw thread of the back panel of the touchscreen is damaged and does not maintain the screw anymore.Therefore, a replacement of the touchscreen, the vga cable and the touchscreen support was advised.The root cause of the damages sustained by the touchscreen, the vga cable and the support of the touchscreen cannot be determined.However, theses parts had been in use for 1 year and 7 months before the damages were noticed (from the installation date, (b)(6) 2018 to the event date, (b)(6) 2020), therefore these parts might have been damaged in use.Corrected data: - b4 date of this report.- g4 date received by manufacturer.- h2 if follow-up, what type.- h3 device evaluated by manufacturer.- h6 event problem and evaluation codes.
 
Event Description
Upon turning the robot stand on, the computer monitor would not turn on.The computer was confirmed to be on by the field service engineer (fse), (b)(4).The robot stand was powered on an off multiple times and the monitor still did not turn on.The back panel had to be removed from the monitor and the vga cable had to be re-seated.This incident caused about a ten minute delay to the case as the patient was already connected to the robot via the head holder.The patient was not harmed during this incident.
 
Manufacturer Narrative
Product was returned at manufacturing site on 09-nov-2020.It appeared that the connector involved was the dvi connector, not the rga connector as stated in the complaint description and the initial and follow-up reports.Inspection of the device did not permit to reproduce the event.Conclusions of the investigation is not challenged, root cause remains unknown.
 
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Brand Name
ROSA ONE
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 Key10342692
MDR Text Key201904220
Report Number3009185973-2020-00186
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K182417
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 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.1.1295
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/23/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received11/03/2020
11/09/2020
Supplement Dates FDA Received11/04/2020
12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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