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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.
 
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.
 
Manufacturer Narrative
Correction: d10; h3 additional information: h6 h3 other text : not returned.
 
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Brand Name
PHOTONGUIDE, WIDE/FLAT
Type of Device
LIGHT, SURGICAL, CARRIER
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key8655906
MDR Text Key146788901
Report Number0001811755-2019-01854
Device Sequence Number1
Product Code FSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Catalogue Number104015
Device Lot NumberAB19011701
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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