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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114100
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2014
Event Type  malfunction  
Event Description
It was reported that the interpulse handpiece with coaxial high flow tip was being used in a procedure when two black o-rings were discovered to be broken.The procedure was completed successfully with no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
Customer discarded the device.
 
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Brand Name
INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3878648
MDR Text Key4567234
Report Number0001811755-2014-02179
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/20/2014
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
Device Operator Health Professional
Device Catalogue Number0210114100
Device Lot Number14111022
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2014
Initial Date FDA Received06/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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