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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA CANNULA D6/2.5MM L200MM COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SA CANNULA D6/2.5MM L200MM COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number N/A
Device Problem Degraded (1153)
Patient Problem No Patient Involvement (2645)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Reportedly, scratches were noticed on the surface of the cannula. The device was conform when leaving the manufacturing site. This event was reported only after surgery, no information about its last utilisation is available. The part was not returned for analysis because of hospital policy restrictions. The technical root cause of the event could not be determined. Udi# : unknown.
 
Event Description
On (b)(6) 2020, after a rosa spine procedure, the user found the scratches on the surface of cannula.
 
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Brand NameCANNULA D6/2.5MM L200MM
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 Key10792526
MDR Text Key214799480
Report Number3009185973-2020-00293
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberROSAS00167
Device Lot NumberROSA3-157A
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 Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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