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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO COAXIAL MULTI ORIFICE TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-KALAMAZOO COAXIAL MULTI ORIFICE TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210058000
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility, the gasket on the irrigator tip was broken.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Event or Problem Description
It was reported that during a procedure at the user facility, the gasket on the irrigator tip was broken.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.
 
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Brand Name
COAXIAL MULTI ORIFICE TIP
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9396579
Report Number0001811755-2019-03888
Device Sequence Number2133568
Product Code FQH
UDI-Device Identifier34546540861505
UDI-Public34546540861505
Combination Product (Y/N)N
Initial Reporter StateCO
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) 06/10/2020
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 Number0210058000
Device Lot Number18075012
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/12/2019
Supplement Date Received by Manufacturer06/10/2020
Initial Report FDA Received Date12/02/2019
Supplement Report FDA Received Date06/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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