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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; REPROCESSED, ARTHOSCOPIC SHAVER SYSTEM BLADE
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STERILMED, INC.; REPROCESSED, ARTHOSCOPIC SHAVER SYSTEM BLADE Back to Search Results
Model Number LINC9248
Device Problems Break (1069); Device Emits Odor (1425); Smoking (1585)
Patient Problem Burn, Thermal (2530)
Event Date 10/10/2018
Event Type  malfunction  
Event Description
Patient in for a scope of right knee.The procedure was going well when a burning smell was noted coming from the full radius resector being used.Upon further inspection, smoke was coming from the instrument and it appeared to be broken.The surgeon stopped the procedure and removed the instrument.He then inspected the knee at the portal site and noted a burn, measuring 10mm wide and 20mm in length.Per response to the hospital, the manufacturer is very concerned about the device and the event.The manufacturer will come get the device when the hospital is ready to release it.
 
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Type of Device
REPROCESSED, ARTHOSCOPIC SHAVER SYSTEM BLADE
Manufacturer (Section D)
STERILMED, INC.
5010 cheshire pkwy n ste 2
plymouth MN 55446
MDR Report Key8037168
MDR Text Key126085567
Report Number8037168
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLINC9248
Device Catalogue NumberLINC9248
Device Lot Number2049547
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/01/2018
Event Location Hospital
Date Report to Manufacturer11/05/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age27375 DA
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