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microTargeting™ Microtable™ Platform – Single 66-MT-D1-00643Recalls & reported problems

Fhc, Inc. · microTargeting(TM) Microtable(TM) Platform – Single · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00873263006436), received between Aug 28, 2019 and Aug 28, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Intracranial Hemorrhage1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    FHC RECEIVED INFORMATION REGARDING AN EVENT RELATING TO THE FHC MICROTABLE, MODEL # 66-MT-D1, SN# (B)(4). THE PATIENT SUFFERED A HEMORRHAGE AND STROKE. PHYSICIAN NOTED THAT THIS WAS NOT THE RESULT OF AN ISSUE WITH THE MICROTABLE. THE MICROTABLE WAS CREATED AND STERILIZED ACCORDING TO THE PLAN FROM THE CT SCANS. THE CASE WENT WELL AND UNEVENTFUL WITH NO INJURY OR CONCERN OF INJURY TO THE PATIENT. THERE WERE 4 BIOPSIES PREPARED AS SPECIMEN FOR PATHOLOGY. THERE WERE AT LEAST 6 PASSES WITH THE BRAIN LAB BIOPSY NEEDLE PERFORMED. THERE WAS NO SIGNIFICANT BLOOD LOSS DURING THE PROCEDURE. THE PATIENT WAS AWAKENED FROM ANESTHESIA AND EXTUBATED. THE PATIENT WAS THEN MOVED TO RECOVERY. RECOVERY ROOM NURSE LATER CALLED THE PHYSICIAN INDICATING THAT THE PATIENT WAS NOT WAKING UP. THE PATIENT WAS EXTUBATED, BREATHING ON HER OWN AND STABLE. AS OF THE DATE OF THIS REPORT, THE PATIENT WAS IN STABLE CONDITION THE MORNING OF (B)(6) 2019.

    Patient problems: Intracranial Hemorrhage

    MAUDE report 8939253 ↗

Other Neurological stereotaxic Instrument devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.