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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 Unintended Collision (1429)
Patient Problem No Code Available (3191)
Event Date 03/06/2015
Event Type  Injury  
Manufacturer Narrative
The device ro 14 035 has been inspected for investigation purpose.The tests performed confirmed that the device was functional and the defect observed could not be linked to any device failure.(b)(4).
 
Event Description
It has been reported that during a surgery, the robotic arm collided with the platform and produced a "communication failure" error and the robot arm was non-functional.It has been reported that the surgery has been aborted.
 
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Brand Name
ROSA SURGICAL DEVICE
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
Manufacturer (Section G)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
Manufacturer Contact
jay sharma
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR   34000
7414400
MDR Report Key6453118
MDR Text Key71493321
Report Number3009185973-2017-00254
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Remedial Action Inspection
Type of Report Initial
Report Date 04/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberROSA 2.5.8
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2015
Initial Date FDA Received04/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/03/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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