PASSIVE BIOPSY NEEDLE
Received Apr 23, 2025 · Event occurred Apr 10, 2025
Report 1723170-2025-01758 · MDR key 21890850
Device
Generic name
Neurological Stereotaxic Instrument
Manufacturer
Quality Tech Services LlcModel number
9733068Catalog number
9733068
Lot number
066503824A
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DETAIL OF THE DEFECT WAS THAT BRAIN PARENCHYMA COULD NOT BE COLLECTED BECAUSE NEGATIVE PRESSURE WAS NOT APPLIED. THIS WAS RESOLVED BY REPLACING WITH A DIFFERENT SERIAL NUMBER. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
H2, H3, H6) UPDATES TO SECTION D. THE 9733068 BIOPSY NEEDLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED BIOPSY NEEDLE HAS NO PHYSICAL DAMAGE. THE MA NUFACTURER REPRESENTATIVE (REP) WAS NOT ABLE TO TEST FOR THE REPORTED FAILURE. OTHERWISE, THE BIOPSY NEEDLE HAD NORMAL TRACKING. CODES B01, C19, AND D14 ARE APPLICABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.