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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION POINTER ELECTROMAGNETIC ENT NAVIGATION ACCESSORIES

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STRYKER INSTRUMENTS-KALAMAZOO PRECISION POINTER ELECTROMAGNETIC ENT NAVIGATION ACCESSORIES Back to Search Results
Model Number 8000-050-001
Device Problems No Device Output (1435); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2020
Event Type  malfunction  
Event Description
It was reported that during a procedure at the user facility the physician used the precision pointer, but bent it above the tip. The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand NamePRECISION POINTER ELECTROMAGNETIC
Type of DeviceENT NAVIGATION ACCESSORIES
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg MI D-791 11
GM D-79111
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10554166
MDR Text Key207550367
Report Number0001811755-2020-02416
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8000-050-001
Device Catalogue Number8000-050-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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