MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CARR-LOCKE INJECTION NEEDLE

Model Number	00711811
Medical Device Problem Codes	Retraction Problem (1536); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event will be returned to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device lot was manufactured to specification.Statements in the instructions for use include: "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.Do not attempt to actuate the injection needle with the catheter in a straightened position.The injection needle has been engineered and manufactured with a specific "preload" that is necessary to assure the full projection and full retraction of the needle from the distal hub when the device is in very tortuous configurations." steris endoscopy has offered in-service training on the use of the carr-lock injection needle to the user facility; however, the user facility has declined.A follow-up mdr will be submitted when additional information becomes available.No additional issues have been reported.
Event or Problem Description
The user facility reported via health (b)(6) report to steris that their carr-locke injection needle failed to retract.There was no report of harm to the patient or user of the device.
Additional Manufacturer Narrative
The steris endoscopy engineering team evaluated the device and could not duplicate the reported event.The device was found to be operating according to specification.No additional issues have been reported.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Common Device Name: INJECTION 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: 13258267
• Report Number: 1528319-2022-00003
• Device Sequence Number: 14968032
• Product Code: FCG
• UDI-Device Identifier: 00724995180881
• UDI-Public: 00724995180881
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 971842
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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 Expiration Date: 01/15/2024
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 2100298
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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