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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA 2.5.8
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2016
Event Type  malfunction  
Manufacturer Narrative
The device has been inspected for investigation purpose. The tests performed confirmed that the articulated arm was non-functional and needed to be replaced. A new support arm was provided to customer to replace the articulated arm.
 
Manufacturer Narrative
Device had not been made available yet.
 
Event Description
At the beginning of the surgery, surgeon attempted to set up articulated arm, but it resisted to tightening movements. The surgeon had to turn the handle really hard to block it in position.
 
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Brand NameROSA SURGICAL DEVICE
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
elise lagacherie
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
467107740
MDR Report Key6215383
MDR Text Key130719797
Report Number3009185973-2016-00009
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 08/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA 2.5.8
Device Catalogue NumberROSAS00003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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