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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 Degraded (1153)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  malfunction  
Manufacturer Narrative
Unique identifier (udi) #: (b)(4). The component was not returned for investigation, but picture was received. One of the side spokes is broken, leading to the vigilance pedal being difficult to appropriately depress. The most probable root cause of this event is a wear of the vigilance device due to frequent handling. The vigilance device was replaced before any other surgery.
 
Event Description
During a maintenance session, the clinical representative (cr) noted the vigilance device was causing several 'vigilance device failure' warnings. Upon further investigation, the cr noted that one of the side spokes was broken, leading to the vigilance pedal being difficult to appropriately depress. Prior to this event, the cr had not known of any complaints or surgery delays from the site.
 
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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 Key11580693
MDR Text Key247284343
Report Number3009185973-2021-00078
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
Report Date 03/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1652
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 Received03/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2018
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

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