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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FHC WAYPOINT STEREOTACTIC PLATFORM STEREOTACTIC INSTRUMENT
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FHC WAYPOINT STEREOTACTIC PLATFORM STEREOTACTIC INSTRUMENT Back to Search Results
Model Number MP-KIT-P-BI
Device Problems Use of Device Problem (1670); Output Problem (3005)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/04/2021
Event Type  malfunction  
Event Description
Incident occurred on (b)(6) 2021, during a bilateral platform case using fhc waypoint stereotactic platform (mp-kit-p-bi). While fitting the platform to the patient, it did not fit. The case had to be cancelled and rescheduled for (b)(6) 2021. After the case was canceled, new scans were complete and the platform was rebuilt using the new scans. The follow up case was completed on (b)(6) 2021 successfully.
 
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Brand NameWAYPOINT STEREOTACTIC PLATFORM
Type of DeviceSTEREOTACTIC INSTRUMENT
Manufacturer (Section D)
FHC
1201 main street
bowdoin ME 04287
Manufacturer (Section G)
FHC, INC.
1201 main street
bowdoin ME 04287
Manufacturer Contact
kelly moeykens
1201 main street
bowdoin, ME 04287
2076665651
MDR Report Key12089004
MDR Text Key261715610
Report Number3002250546-2021-00001
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092192
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 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMP-KIT-P-BI
Device Catalogue NumberMP-KIT-P-BI
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
Was Device Evaluated by Manufacturer? Yes
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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