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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PHOTONGUIDE, NARROW/FLAT; LIGHT, SURGICAL, FIBEROPTIC
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STRYKER INSTRUMENTS-KALAMAZOO PHOTONGUIDE, NARROW/FLAT; LIGHT, SURGICAL, FIBEROPTIC Back to Search Results
Model Number NARROW / FLAT
Device Problems Fracture (1260); Overheating of Device (1437)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2020
Event Type  malfunction  
Event Description
It was reported that prior to a surgical procedure at the user facility, the product broke.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.H3 other text: discarded by user.
 
Event Description
It was reported that prior to a surgical procedure at the user facility, the product broke.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
 
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Brand Name
PHOTONGUIDE, NARROW/FLAT
Type of Device
LIGHT, SURGICAL, FIBEROPTIC
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9928476
MDR Text Key186697759
Report Number0001811755-2020-00867
Device Sequence Number1
Product Code FST
UDI-Device Identifier00816728021650
UDI-Public00816728021650
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNARROW / FLAT
Device Catalogue Number104008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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