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

Model Number	00711810
Medical Device Problem Codes	Retraction Problem (1536); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and confirmed the device lot was manufactured to specification.Statements from instructions for use packet include, "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." steris has requested the device subject of the event to be returned for evaluation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their articulator injection needle was not operating properly causing a procedure delay.The user facility personnel used an additional device to complete the procedure.No report of injury.
Additional Manufacturer Narrative
Six unused devices from the same lot were returned by the user facility for evaluation.All six devices deployed and retracted as expected.A syringe was able to attach to all six luers without issue and the luers were able to lockdown to the handle assembly without issue.The device subject of the reported event was not returned for evaluation.Without the return of the device subject of the reported event the cause of the reported issue cannot be determined.The distributor 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: 15970259
• Report Number: 1528319-2022-00064
• Device Sequence Number: 4912856
• Product Code: FCG
• UDI-Device Identifier: 10724995180871
• UDI-Public: 00724995180874
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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 Expiration Date: 01/08/2024
• Device Model Number: 00711810
• Device Catalogue Number: 00711810
• Device Lot Number: 2200249
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2022
• 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