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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. METRX ENDOSCOPE ARTHROSCOPE

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MEDTRONIC SOFAMOR DANEK USA, INC. METRX ENDOSCOPE ARTHROSCOPE Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2016
Event Type  malfunction  
Event Description
After removing k-wire from patient's incision, the doctor passed a k-wire through metrx tube. Neither the k-wire or the metrx tube was in the patient's incision at this time. When the k-wire was passed through the metrx tube, brown discharge was pushed out of the end of the metrx tube. The tube, k-wire, and metrx tube set were removed from the sterile field and new sterile towels were placed on the field. No patient harm.
 
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Brand NameMETRX ENDOSCOPE
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
4340 swinnea road
memphis TN 38118
MDR Report Key6085097
MDR Text Key59386711
Report Number6085097
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/28/2016,10/31/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2016
Event Location Hospital
Date Report to Manufacturer10/28/2016
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

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