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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL KNIFE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450815100
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/17/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the blade broke.The user facility reported that the procedure was completed successfully without a clinically significant delay, and that there were no adverse consequences or medical interventions.
 
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the blade broke.The user facility reported that the procedure was completed successfully without a clinically significant delay, and that there were no adverse consequences or medical interventions.
 
Additional Manufacturer Narrative
Device not returned.
 
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Brand Name
SONIC CONTROL KNIFE, UNIVERSAL
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7984211
Report Number0008043928-2018-00109
Device Sequence Number16185455
Product Code LFL
UDI-Device Identifier37613252518397
UDI-Public37613252518397
Combination Product (Y/N)N
Initial Reporter CountryFR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/05/2019
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 Number5450815100
Device Lot NumberM0010089
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/22/2018
Supplement Date Received by Manufacturer06/05/2019
Initial Report FDA Received Date10/19/2018
Supplement Report FDA Received Date06/05/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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