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

Model Number	00711807
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure which included use of the articulator injection needle, the needle tip could not be withdrawn into the device.Another articulator injection needle was utilized to complete the procedure.No report of patient harm.
Additional Manufacturer Narrative
The device subject of the report is being returned to steris endoscopy for evaluation.The instructions for use provides the following information when using the articulator - injection needle, "for articulator & carr-locke injection needles only: 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." the device history record was reviewed, and no abnormalities were identified.A three-year complaint review for this product indicates this to be an isolated occurrence.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The articulator injection needle subject of the event was returned for evaluation.Evaluation results confirmed that the needle was not retracting as stated in the reported event.Steris offered in-service training on the proper use and operation of the articulator injection needle however, the user facility declined.No additional issues have been reported.

• Brand Name: ARTICULATOR INJECTION NEEDLE
• Common Device Name: BIOPSY 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: 16254438
• Report Number: 1528319-2023-00003
• Device Sequence Number: 14821046
• Product Code: FCG
• UDI-Device Identifier: 00724995180850
• UDI-Public: 00724995180850
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711807
• Device Catalogue Number: 00711807
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• 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