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U.S. Department of Health and Human Services

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

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MEDTECH SA ROSA ONE COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number SEEG DRILL ADAPTOR 2.45MM
Device Problem Degraded (1153)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device was conform on leaving manufacturing site. This part was not returned for investigation, the technical root cause of the event could not be determined. However, this topic is addressed through a capa, and the conclusion of the investigations already performed, concluded that the drill adaptor design must be improved. Unique identifier (udi) #: unknown.
 
Event Description
The clinical representative (cr) was present for a seeg case. Once the surgeon was ready to begin drilling, he noticed that there was a strange catch in the 2. 45 drill adaptor, and that the bolt and driver would not pass through it easily. The surgeon swapped out the drill adaptor for a different one, and was able to continue the case without any problems. Delay to case about 5 mins, after patient was under anesthesia, and after first incision. No patient impact.
 
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Brand NameROSA ONE
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 Key10842649
MDR Text Key218239054
Report Number3009185973-2020-00304
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSEEG DRILL ADAPTOR 2.45MM
Device Catalogue NumberROSAS00082
Device Lot NumberROSA3-283A
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 Received10/09/2020
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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