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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114000
Device Problem Biocompatibility (2886)
Patient Problem No Patient Involvement (2645)
Event Date 10/16/2017
Event Type  malfunction  
Event Description
The user facility reported that the device had a black fiber on the white cable in the package during a product check.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 had a black fiber on the white cable in the package during a product check.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
INTERPULSE HANDPIECE WITH 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 Key6984358
MDR Text Key91195279
Report Number0001811755-2017-02295
Device Sequence Number1
Product Code FQH
UDI-Device Identifier4546540673565
UDI-Public(01)4546540673565
Combination Product (y/n)N
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 11/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210114000
Device Lot Number17108012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received11/06/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2017
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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