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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE STERILIZATION CASE, SMALL
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STRYKER INSTRUMENTS-KALAMAZOO CORE STERILIZATION CASE, SMALL Back to Search Results
Catalog Number 5400276000
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Cataract (1766); Retinal Injury (2048)
Event Date 01/08/2019
Event Type  Injury  
Event Description
The user facility reported that the device handle apparently broke off when the user tried to pull the case out of a cart.It is the user facility position that the handle hit the user in the eye and caused a retinal detachment for which the user has had three surgeries and has further developed a cataract.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results device not returned, location unknown.
 
Event Description
The user facility reported that the device handle apparently broke off when the user tried to pull the case out of a cart.It is the user facility position that the handle hit the user in the eye and caused a retinal detachment for which the user has had three surgeries and has further developed a cataract.
 
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Brand Name
CORE STERILIZATION CASE, SMALL
Type of Device
CORE STERILIZATION CASE, SMALL
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
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key8351616
MDR Text Key136537856
Report Number0001811755-2019-00582
Device Sequence Number1
Product Code FSM
UDI-Device Identifier04546540427328
UDI-Public04546540427328
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5400276000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2019
Was Device Evaluated by Manufacturer? No
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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