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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 LT WT FIBER OPT SURG HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T5 LT WT FIBER OPT SURG HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0400635000
Device Problems Melted (1385); Overheating of Device (1437)
Patient Problem No Patient Involvement (2645)
Event Date 06/15/2015
Event Type  malfunction  
Event Description
It was reported that during testing at the manufacturer facility the tip of the device cord overheated and melted.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device was scrapped by stryker.
 
Event Description
It was reported that during testing at the manufacturer facility the tip of the device cord overheated and melted.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
Failure analysis is still in progress.
 
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Brand Name
T5 LT WT FIBER OPT SURG HELMET
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 Key4928496
MDR Text Key6195996
Report Number0001811755-2015-02639
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeUS
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 06/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0400635000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/21/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2014
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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