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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PHOTONGUIDE, WIDE/FLAT LIGHT, SURGICAL, CARRIER

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STRYKER INSTRUMENTS-KALAMAZOO PHOTONGUIDE, WIDE/FLAT LIGHT, SURGICAL, CARRIER Back to Search Results
Catalog Number 104015
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2019
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure at the user facility, the photonbuide broke in half. The procedure was completed successfully without a clinically significant delay, adverse consequences, or medical intervention.
 
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Brand NamePHOTONGUIDE, WIDE/FLAT
Type of DeviceLIGHT, SURGICAL, CARRIER
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 Key8655906
MDR Text Key146788901
Report Number0001811755-2019-01854
Device Sequence Number1
Product Code FSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number104015
Device Lot NumberAB19011701
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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