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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET Back to Search Results
Catalog Number 0210100000
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/30/2021
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: 15 events were reported for this quarter.Product return status: 14 devices were received.1 device was not available for evaluation.Additional information: 15 devices were labeled for single-use.15 devices were not reprocessed or reused.
 
Event or Problem Description
This report summarizes 15 malfunction events in which the device was reportedly leaking.15 events had patient involvement; no patient impact.
 
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Brand Name
INTERPULSE HANDPIECE SET WITH SUCTION TUBING
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
*  00615
MDR Report Key12715293
Report Number3015967359-2021-02431
Device Sequence Number17203359
Product Code FQH
UDI-Device Identifier34546540144219
UDI-Public34546540144219
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized15
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/28/2021
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 Number0210100000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/30/2021
Initial Report FDA Received Date10/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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