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

Model Number	00711807
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their articulator injection needles failed to deploy causing a procedure delay.The user facility personnel used an additional device to complete the procedure.No report of injury.
Additional Manufacturer Narrative
The customer could not confirm if user facility personnel tested the device prior to clinical use in accordance with the instructions for use.Statements from instructions for use packet, "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.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." one of the devices subject of the event was returned, and evaluation found that the needle was capable of deployment.There have been no other complaints associated with devices from this lot, and no additional issues reported by the user facility.

• 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: 14597477
• Report Number: 1528319-2022-00031
• Device Sequence Number: 16668649
• Product Code: FCG
• UDI-Device Identifier: 00724995180850
• UDI-Public: 00724995180850
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 06/03/2022

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: 2112394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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