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

Model Number	00711811
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to steris endoscopy for evaluation.The device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.A steris endoscopy representative discussed the reported event with user facility personnel and determined that the facility does not actuate the needle deployment prior to use, as specified in the device instructions for use.The instructions for use include the following statements: "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." steris endoscopy has provided in-service training on the use of the device, specifically confirming deployment prior to introduction to the scope.There have been no further issues reported.
Event or Problem Description
Reference user facility medwatch # (b)(4), which reported the carr-locke injection needle failed to deploy during procedural use.The device was immediately replaced with another carr-locke injection needle, and the procedure was completed.There were no injuries associated with the reported event.

• 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
• MDR Report Key: 9548275
• Report Number: 1528319-2020-00001
• Device Sequence Number: 3414186
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K971842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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: 11/20/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1911648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1