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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO FLYTE HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0408600000
Device Problem Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
Product not available.
 
Event Description
The customer reported that the flyte helmet has overheated and burned a health care professional during surgery.Attempts were made to obtain additional information about the event; no further information was received.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
The customer reported that the flyte helmet has overheated and burned a health care professional during surgery.Attempts were made to obtain additional information about the event; no further information was received.
 
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Brand Name
FLYTE HELMET
Type of Device
HELMET, SURGICAL
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8619695
MDR Text Key145375097
Report Number0001811755-2019-01715
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0408600000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Date Manufacturer Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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