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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET (.7-1.8MM)
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STRYKER INSTRUMENTS-KALAMAZOO WIRE COLLET (.7-1.8MM) Back to Search Results
Catalog Number 4100062000
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2018
Event Type  malfunction  
Event Description
The user facility reported that the device was leaking during a case.  there was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The user facility reported that the device was leaking during a case.   there was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand NameWIRE COLLET (.7-1.8MM)
Type of DeviceWIRE COLLET (.7-1.8MM)
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8199181
MDR Text Key131501839
Report Number0001811755-2018-02903
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4100062000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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