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

Model Number	00711811
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure, the handle to their carr-locke injection needle device came apart and was not operating properly.No report of injury.
Additional Manufacturer Narrative
Steris requested the carr-locke injection needle device back for evaluation.The information for use packet (ifu 730700) provides the following information when using the articulator¿ - injection needle and the carr-locke injection needles, see below."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." the device history record was reviewed and confirmed the lot subject of the event was manufactured to specification.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.The evaluation determined the handle components had separated due to insufficient adhesive at the connection between the components.A review of complaints determines this to be an isolated event.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: 15640442
• Report Number: 1528319-2022-00053
• Device Sequence Number: 12391799
• Product Code: FCG
• UDI-Device Identifier: 00724995180881
• UDI-Public: 00724995180881
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 10/20/2022

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: 00711811
• Device Catalogue Number: 00711811
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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