MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. MICRO-TECH ENDOSCOPY INJECTION NEEDLE; ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number	IN33240
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2024
Type of Reportable Event	Other
Event or Problem Description
Injection needle has a clear tip cover that is the same color as the tubing and easily fits through the scope channel.The user inadvertently forgot to remove the tip cover and the tip came off in the patients colon and had to be retrieved.There was no injury to patient due to this error.Recommend tip cover color and size be revised to avoid future incident.

• Brand Name: MICRO-TECH ENDOSCOPY INJECTION NEEDLE
• Common Device Name: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.; nanjing, jiangsu province 21003 2; CH 210032
• MDR Report Key: 18799723
• Report Number: MW5152104
• Device Sequence Number: 7248140
• Product Code: FBK
• UDI-Device Identifier: 06932503533249
• UDI-Public: (01)06932503533249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2026
• Device Model Number: IN33240
• Device Catalogue Number: IN12-255232302
• Device Lot Number: M230117321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2024
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White