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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE LIGHTED HELMET BP; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE LIGHTED HELMET BP; HELMET, SURGICAL Back to Search Results
Catalog Number 0408645000
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/10/2016
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis.
 
Event Description
It was reported that during a surgical procedure at the user facility the device heated up.It was reported that a loose thread from the surgical hood was entangled in the fan.There was no surgical delay, no medical intervention and no adverse consequences.
 
Event Description
It was reported that during a surgical procedure at the user facility the device heated up.It was reported that a loose thread from the surgical hood was entangled in the fan.There was no surgical delay, no medical intervention and no adverse consequences.
 
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Brand Name
FLYTE LIGHTED HELMET BP
Type of Device
HELMET, SURGICAL
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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5778172
MDR Text Key49029828
Report Number0001811755-2016-01089
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0408645000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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