MAUDE Adverse Event Report: MICRO-TECH (NAN JING) CO., LTD. ENDOINK; MARKER, COLON

Model Number ENK10

Device Problem Connection Problem (2900)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Endoink¿, a single-use fluid designed to endoscopically mark lesions in the gastrointestinal tract, would not attached to the carr-locke injection needle.A new endoink¿ needle was obtained and case continued witouth issue.

• Brand Name: ENDOINK
• Type of Device: MARKER, COLON
• Manufacturer (Section D): MICRO-TECH (NAN JING) CO., LTD.; 2855 boardwalk drive; ann arbor MI 48104
• MDR Report Key: 14346020
• MDR Text Key: 295251020
• Report Number: 14346020
• Device Sequence Number: 1
• Product Code: NBG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ENK10
• Device Catalogue Number: ENK10
• Device Lot Number: M210726252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Date Report to Manufacturer: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA