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

Model Number	00711811
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon follow up with the user facility, steris endoscopy has confirmed that the reported event occurred prior to patient use.There was no harm to the patient or user.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The device subject of this complaint was returned to steris endoscopy for evaluation, which found the internal catheter of the needle was kinked and broken away at the attachment to the handle assembly.This condition may be the result of user handling, specifically device articulation while tightly coiled or extreme articulation near the handle assembly.Statements from the instructions for use prior to insertion of the device into the endoscope include: "actuate the proximal luer back and forth, visually observing the needle being adequately advanced from the device's distal end.Do not attempt to actuate the injection needle with the catheter in a straightened position." steris endoscopy has offered in-service training on the use of the carr-locke injection needle; however, the user facility has declined.
Event or Problem Description
Steris endoscopy received user facility medwatch report number mw5095298, which reported that a carr-locke injection needle failed to deploy.

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Common Device Name: INJECTION NEEDLE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10521132
• Report Number: 1528319-2020-00031
• Device Sequence Number: 14158861
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K971842
• 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
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 10/28/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1914944
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1