MAUDE Adverse Event Report: US ENDOSCOPY CARR-LOCKE; BIOPSY NEEDLE

Model Number	00711811
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Us endoscopy injection needle would not 'lock'.Nurse held in position to conclude procedure.No harm came to the patient.

• Brand Name: CARR-LOCKE
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8935446
• Report Number: 8935446
• Device Sequence Number: 11262710
• Product Code: FCG
• UDI-Device Identifier: 00816765011898
• UDI-Public: (01)00816765011898
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019
• Report Date (Section F): 07/12/2019

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
• Device Lot Number: 1900285
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/12/2019