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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH ROSA® BRAIN NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTECH ROSA® BRAIN NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 3.0.1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 09/26/2019
Event Type  malfunction  
Event Description
During a procedure, upon verifying our registration, the pointer probe inadvertently caused a superficial laceration. The rosa was emergently disconnected. The surgeon feels there is no relationship of the occurrence to a previously released recall.
 
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Brand NameROSA® BRAIN
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTECH
56 east bell drive
warsaw IN 46581
MDR Report Key9494826
MDR Text Key172009480
Report Number9494826
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3.0.1
Device Catalogue NumberROSAS00303
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/11/2019
Device Age9 MO
Event Location Hospital
Date Report to Manufacturer12/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
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