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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 Biocompatibility (2886)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2017
Event Type  malfunction  
Event Description
The user facility reported that the device's tubing had a sticky film and a blue tinge prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
The reported event was not confirmed during the device evaluation.
 
Event Description
The user facility reported that the device's tubing had a sticky film and a blue tinge prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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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 00615
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6463664
MDR Text Key71894526
Report Number0001811755-2017-00826
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/08/2017
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 Number16165022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2017
Initial Date FDA Received04/06/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2016
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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