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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP; LAVAGE, JET

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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210918100
Device Problem Biocompatibility (2886)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  malfunction  
Event Description
The user facility reported that the device and the packaging had a white powdery residue found during set up, prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
The reported event was confirmed during the device evaluation.
 
Event Description
The user facility reported that the device and the packaging had a white powdery residue found during set up, 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 FAN SPRAY 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 Key6177312
MDR Text Key62461869
Report Number0001811755-2016-02854
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 01/26/2017
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 Number0210918100
Device Lot Number16224012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2016
Initial Date FDA Received12/15/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2016
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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