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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH NEPHEW, INC. CORI HANDPIECE AND CORI REAL INTELLIGENCE ORTHOPEDIC STEREOTAXIC INSTRUMENT

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SMITH NEPHEW, INC. CORI HANDPIECE AND CORI REAL INTELLIGENCE ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number REAL INTELLIGENCE # 000031 HANDPIECE # 500184
Device Problem Separation Failure (2547)
Patient Problem Insufficient Information (4580)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
Attachment would not release from cori handpiece. Console error message. During shutdown of cori console, the electronic message is sent to disengage the attachment from the handpiece. This failed. Handpiece sent to smith and nephew for repair.
 
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Brand NameCORI HANDPIECE AND CORI REAL INTELLIGENCE
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
SMITH NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key12827666
MDR Text Key280885401
Report Number12827666
Device Sequence Number1
Product Code OLO
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 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREAL INTELLIGENCE # 000031 HANDPIECE # 500184
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2021
Device Age12 MO
Event Location Hospital
Date Report to Manufacturer11/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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