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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T5 SURGICAL HELMET; HELMET, SURGICAL
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STRYKER INSTRUMENTS-KALAMAZOO T5 SURGICAL HELMET; HELMET, SURGICAL Back to Search Results
Catalog Number 0400610000
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2015
Event Type  malfunction  
Manufacturer Narrative
Failure analysis is in progress.
 
Event Description
It was reported that during a surgical procedure at the user facility the device was overheating.The user facility was not able to provide any further information regarding the reported event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a surgical procedure at the user facility the device was overheating and smoking.The user facility was not able to provide any further information regarding the reported event.
 
Manufacturer Narrative
Device was scrapped by stryker.
 
Event Description
It was reported that during a surgical procedure at the user facility the device was overheating and smoking.The user facility was not able to provide any further information regarding the reported event.
 
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Brand Name
T5 SURGICAL 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 Key5092225
MDR Text Key26377712
Report Number0001811755-2015-03482
Device Sequence Number1
Product Code FXZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Nurse
Type of Report Followup
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0400610000
Device Lot Number09223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2009
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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