MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE; BIOPSY NEEDLE

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	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, the device had not been returned for investigation.Device was not used during the procedure.
Event or Problem Description
21ga needle would not retract back into sheath during procedure set up and prior to insertion into the scope.
Additional Manufacturer Narrative
This report is being supplemented to provide information that was inadvertently not included in the initial medwatch report and to provide the results of the investigation of the returned device.G3: date received by manufacturer was blank in the initial medwatch report and should have been 23-aug-2022.The subject device was returned for evaluation.The reported issue was able to be replicated.The needle was extended outside of the sheath and actuating the handle did not retract the needle tip or extend the needle tip further.Further inspection and removal of the strain relief revealed that actuating the handle would push the pull-wire, but since the needle was already at full extension and would not go beyond the needle stop and the end of the sheath, this only caused the pull-wire to curl along with the sheath.The sheath length was measured to determine whether the needle was exposed because of a short sheath, but the sheath was found to be within specification, although on the shorter end.A review of the risk documentation indicates the potential root causes are an error in design or assembly during manufacturing; however, a definitive root cause could not be determined.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• Brand Name: ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 15422498
• Report Number: 3007222345-2022-00021
• Device Sequence Number: 2556310
• Product Code: JAK
• UDI-Device Identifier: 00815686020613
• UDI-Public: 00815686020613
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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 Expiration Date: 12/16/2023
• Device Model Number: INS-0392
• Device Catalogue Number: INS-0392
• Device Lot Number: 04777201113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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 Sex: Unknown