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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-INAGI ANGLED CURETTE W/O TIP; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-INAGI ANGLED CURETTE W/O TIP; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450814000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/02/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the device was heating up.The user facility reported that the procedure was completed successfully without a delay, and that there were no adverse consequences or medical intervention.
 
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
 
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the device was heating up.The user facility reported that the procedure was completed successfully without a delay, and that there were no adverse consequences or medical intervention.
 
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Brand Name
ANGLED CURETTE W/O TIP
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-INAGI
1131-1 higashi naganuma
inagi 206-0 802
MDR Report Key7721894
Report Number0008043928-2018-00078
Device Sequence Number1040487
Product Code LFL
UDI-Device Identifier07613327289893
UDI-Public07613327289893
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/16/2019
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
Operator of Device Health Professional
Device Catalogue Number5450814000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2018
Initial Date Received by Manufacturer 07/03/2018
Supplement Date Received by Manufacturer04/16/2019
Initial Report FDA Received Date07/26/2018
Supplement Report FDA Received Date04/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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