MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE,15MM L, 1.8 OD STYLET; CT STEROTACTIC ACCESSORY

Model Number	INS-0392
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus the always-on tip tracked 21ga anso cytology needle failed to retract.The issue occurred during an endotracheal bronchoscopy.One needle was tested before use and failed to retract.Another needle from the same lot was retrieved, tested, and used to gather tissue samples, but failed to retract once inside the patient when there was no failure outside the patient.There were no reports of patient harm or impact.The user facility reported this event under medwatch 4200820000-2023-8005.This event is reported under the following patient identifiers: (b)(6): first device (failed to retract prior to patient insertion); (b)(6): second device (failed to retract while inside the patient).This medical device report is for patient identifier (b)(6).
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, but the investigation is in progress.Follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
Correction to the initial medwatch as the subject device will not be evaluated as this complaint is related to a product that is currently being removed from the market.Therefore, this device is being investigated under an unrelated recall.If additional information becomes available, this report will be supplemented accordingly.

• Brand Name: ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE,15MM L, 1.8 OD STYLET
• Common Device Name: CT STEROTACTIC ACCESSORY
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center drive; st.louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center drive; st.louis MO 63114
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17484692
• Report Number: 3007222345-2023-00151
• Device Sequence Number: 7246103
• Product Code: JAK
• UDI-Device Identifier: 00815686020613
• UDI-Public: 00815686020613
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INS-0392
• Device Lot Number: 04989210205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic