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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET
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STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET Back to Search Results
Catalog Number 0210200000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/31/2020
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: 1 device was found to be affected by a broken battery port / stem.1 device was labeled for single-use.1 device was not reprocessed or reused.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reportedly leaking.1 event had patient involvement; no patient impact.
 
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Brand Name
INTERPULSE IRRIGATION ONLY HANDPIECE
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9997047
Report Number0001811755-2020-01060
Device Sequence Number11872702
Product Code FQH
UDI-Device Identifier34546540144264
UDI-Public34546540144264
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/24/2020
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 No Information
Device Catalogue Number0210200000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/24/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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