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

Model Number IN12-255232302

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

The event that happened with both devices was there was a hole in the catheter which allowed the spot ink to spill out and not be injected in the mucosa.No harm was caused.Fda safety report id# (b)(4).

• Brand Name: MICROTECH
• Type of Device: ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): MICRO-TECH (NAN JING) CO., LTD.
• MDR Report Key: 10683225
• MDR Text Key: 211696478
• Report Number: MW5097220
• Device Sequence Number: 1
• Product Code: FBK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2022
• Device Model Number: IN12-255232302
• Device Catalogue Number: IN12-255232302
• Device Lot Number: M190826326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR