• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTECH SA ROSA SURGICAL DEVICE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA 2.5.8
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Memory Loss/Impairment (1958); Paresis (1998); Coma (2417)
Event Date 07/10/2017
Event Type  Injury  
Manufacturer Narrative
The device (b)(4) has been inspected for investigation purpose. Based on the available information the incident was identified to be due to the following probable root causes: incorrect checking of the registration result by the operating surgeon, undetected patient head motion during the surgery, two electrodes may have passed through a vessel due to robot arm inaccurate position during the case, this inaccuracy most probably being due to the undetected patient head motion. Corrected data: date of this report; date received by manufacturer; evaluation code.
 
Manufacturer Narrative
As per additional information received from the hospital the patient is doing it a bit better and can speak normally without problem. The nasogastric probe has been removed and patient can eat also without problems. Patient still has some amnesia and some right hemiparesia but overall can stand up and walk without help.
 
Manufacturer Narrative
The operating surgeon indicated that there were no apparent issues noted intra-operatively and that the rosa device ro12020 had not malfunctioned during the subject surgery. The device has not been evaluated yet for investigation purpose. A medtech representative will go on customer site to inspect the device and determine the root cause of event. Once the evaluation will be performed, a follow-up medwatch report will be submitted.
 
Event Description
The surgeon reported that the patient underwent a seeg procedure to implant electrodes. The procedure was completed and the patient was transferred to the recovery room. It was stated that whilst in the recovery room that the patient suffered an acute subdural hematoma, lost consciousness and was transferred to the operating room for subdural haematoma evacuation. Additional information provided later by the operating surgeon indicates that there were no apparent issues noted intra-operatively and that the rosa device had not malfunctioned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key6803336
MDR Text Key117872959
Report Number3009185973-2017-00702
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PK101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA 2.5.8
Device Catalogue NumberN/A
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2012
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: 08/18/2017 Patient Sequence Number: 1
-
-