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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 HELMET W/ T4 FIBER OPTIC LIGHT; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T5 HELMET W/ T4 FIBER OPTIC LIGHT; HELMET, SURGICAL Back to Search Results
Catalog Number 0400675000
Device Problem Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
Evaluation in progress.
 
Event Description
It was reported that during a surgical procedure a helmet over heated and the physician's forehead was burned.No medical intervention, adverse consequences, or delays to a surgical procedure was reported with the event.
 
Event Description
It was reported that during a surgical procedure a helmet over heated and the physician's forehead was burned.No medical intervention, adverse consequences, or delays to a surgical procedure was reported with the event.
 
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Brand Name
T5 HELMET W/ T4 FIBER OPTIC LIGHT
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 Key6185057
MDR Text Key62700239
Report Number0001811755-2016-02861
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
A888389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400675000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2014
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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