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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 3.1
Device Problem Malposition of Device (2616)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2020
Event Type  Injury  
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. Unique identifier (udi) #: (b)(4).
 
Event Description
When registering, the robot started to move on its own in different directions. The clinical representative (cr) shut down the robot and recalibrated the pointer probe to register. The arm stopped drifting on its own, but was still difficult to work with. The cr and the surgeon decided to continue on with the surgery since they got a 0. 7 rms and the verification looked good. When they merged the inter-operative scan, the biopsy needle was about 9mm lateral from the planned trajectory. A converted surgery had to be done: the surgeon had to use the stealth to complete the procedure. There was no injury to the patient but a delay > 30 minutes was observed.
 
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Brand NameROSA ONE
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 Key10829913
MDR Text Key217325498
Report Number3009185973-2020-00302
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1650
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/09/2018
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: 11/12/2020 Patient Sequence Number: 1
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