MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ARTICULATOR INJECTION NEEDLE

Model Number	00711807
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation as the user facility discarded the device.Without the returned device the root cause of the reported event cannot be determined.The injection needles information for use states, "carefully remove the tip protector from the distal tip of the needle.Actuate the proximal luer back and forth, visually observing the needle being adequately advanced from the device's distal end.The spring-loaded handle assists in needle retraction; however, always visually check the retraction as well.Note: do not stretch the device because stretching may cause the needle projection length to be altered.To lock the needle in the out position, gently press the proximal luer until it meets the handle's luer, and then slowly twist the proximal luer clockwise until the two luers are fully engaged.Ensure that the needle is fully retracted prior to inserting it into the endoscope.To unlock the needle, slowly twist the proximal luer counterclockwise until the two luers disengage." the device history record was reviewed, and no abnormalities were identified.A three-year complaint review for this lot indicates this to be an isolated occurrence.No additional issues were noted.
Event or Problem Description
The user facility reported via vigilance report that during a patient procedure which included use of an injection needle the device would not withdraw the needle.Another injection needle was utilized to complete the procedure.No report of patient harm.

• Brand Name: ARTICULATOR INJECTION NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 14242104
• Report Number: 1528319-2022-00023
• Device Sequence Number: 4445380
• Product Code: FCG
• UDI-Device Identifier: 00724995180850
• UDI-Public: 00724995180850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 00711807
• Device Catalogue Number: 00711807
• Device Lot Number: 2110642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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