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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-KALAMAZOO 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 06/04/2014
Event Type  malfunction  
Event Description
It was reported that when the interpulse handpiece with coaxial high flow tip was opened for use prior to a procedure, the device fell onto the table broken.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.Device is not yet received.
 
Event Description
It was reported that when the interpulse handpiece with coaxial high flow tip was opened for use prior to a procedure, the device fell onto the table broken.The procedure was completed successfully, with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
The unit was received in its original blister with label; it appeared to be unused.A broken o-ring was taped to the blister tray; thus confirming the reported condition.Upon visual inspection of the tip, it was confirmed that the broken o-ring corresponded to the tip.No further assembly issues were observed on the tip and/or the handpiece.A definite root cause could not be determined.The device was scrapped at the manufacturer.
 
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Brand Name
INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
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 Key3907671
MDR Text Key4588514
Report Number0001811755-2014-02358
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,Followup
Report Date 06/05/2014
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 Number14107012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/01/2014
Initial Date FDA Received07/01/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2014
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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