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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 LEKSELL FRAME ADAPTOR
Device Problem Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 02/19/2018
Event Type  malfunction  
Manufacturer Narrative
The leksell frame adaptor from the device (b)(4) has not been evaluated yet for investigation purpose. Once the evaluation will be performed, a follow-up medwatch report will be submitted.
 
Event Description
After the assisted surgery, the field safety engineer found worn out screws of the leksell frame adaptor.
 
Manufacturer Narrative
Visual inspection of returned screws showed that the head of the two screws are damaged. This damage is probably due to a repetitive and an excessive tightening. These screws are often used as they are screwed every time the leksell frame adaptor is used. This is a normal wear of the screws, they were replaced precautionary on the 08-mar-2018 for repair purpose.
 
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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
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 Key7295612
MDR Text Key101122792
Report Number3009185973-2018-00051
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PK101791
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLEKSELL FRAME ADAPTOR
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 Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
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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