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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114000
Medical Device Problem Code Delivered as Unsterile Product (1421)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/30/2020
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 not available for evaluation.1 device was labeled for single-use.1 device was not reprocessed or reused.Device not returned.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had debris in sterile package.1 event had no patient involvement; no patient impact.
 
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Brand Name
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
PR  00615
MDR Report Key10329781
Report Number0001811755-2020-01888
Device Sequence Number16377817
Product Code FQH
UDI-Device Identifier34546540673566
UDI-Public34546540673566
Combination Product (Y/N)N
Initial Reporter StateMI
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) 07/27/2020
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 Number0210114000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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