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

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Endoink luer cap would not stay attached to syringe.New device obtained and case continued without incident.Unfortunately, device and packaging discarded during case.

• 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: 14955710
• MDR Text Key: 295496014
• Report Number: 14955710
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/22/2022
• Date Report to Manufacturer: 07/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18980 DA