Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FHC WAYPOINT STEREOTACTIC PLATFORM; STEREOTACTIC INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Manufacturer Narrative
Fhc is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by fhc, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Fhc has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, fhc, or its employees that the device, fhc or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Fhc objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WAYPOINT STEREOTACTIC PLATFORM
Type of Device
STEREOTACTIC INSTRUMENT
Manufacturer (Section D)
FHC
1201 main street
bowdoin ME 04287
MDR Report Key12089004
MDR Text Key261715610
Report Number3002250546-2021-00001
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00873263005903
UDI-Public00873263005903
Combination Product (y/n)N
PMA/PMN Number
K092192
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberMP-KIT-P-BI
Device Catalogue NumberMP-KIT-P-BI
Date Manufacturer Received06/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-