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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING; INSTRUMENT, ULTRASONIC SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number 5450850003
Medical Device Problem Code Inability to Irrigate (1337)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was received.Event confirmation status: 1 reported event was confirmed.Evaluation results: the root cause could not be established.Additional information: 1 device was labeled for single-use.1 device was not reprocessed and reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device experienced an irrigation issue that could lead to overheating.1 event had patient involvement; no patient impact.
 
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Brand Name
DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING
Common Device Name
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8816435
Report Number0001811755-2019-02375
Device Sequence Number2562592
Product Code LFL
UDI-Device Identifier34546540716201
UDI-Public34546540716201
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/23/2019
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 No Information
Device Catalogue Number5450850003
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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