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

Model Number IN33240

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2024

Event Type  Other  

Event 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
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.; nanjing, jiangsu province 21003 2; CH 210032
• MDR Report Key: 18799723
• MDR Text Key: 336564012
• Report Number: MW5152104
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 06932503533249
• UDI-Public: (01)06932503533249
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White