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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET
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STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET Back to Search Results
Catalog Number 0210100000
Device Problem Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2018
Event Type  malfunction  
Event Description
The user facility reported that during case preparation, the battery had melted to the plastic packaging.There was no patient involvement, medical delay or adverse consequences.
 
Event Description
The user facility reported that during case preparation, the battery had melted to the plastic packaging.There was no patient involvement, medical delay or adverse consequences.
 
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Brand Name
INTERPULSE HANDPIECE SET WITH SUCTION TUBING
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
highway #3, km 130.2
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7455433
MDR Text Key106407027
Report Number0001811755-2018-00627
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 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0210100000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received06/22/2018
Was Device Evaluated by Manufacturer? Yes
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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