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

Catalog Number ENK10

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 04/09/2022

Event Type  malfunction  

Event Description

The luer tip of the endoinktm endoscopic marker leaked when attached to syringe.A new setup was obtained and case continued without incident.The original device and packaging were discarded after numbers attached, education provided to save items even if messy.

• Brand Name: ENDOINK
• Type of Device: ENDOSCOPIC MARKER
• Manufacturer (Section D): MICRO-TECH (NAN JING) CO., LTD.; 2855 boardwalk drive; ann arbor MI 48104
• MDR Report Key: 14999540
• MDR Text Key: 295778547
• Report Number: 14999540
• 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: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ENK10
• Device Lot Number: M210719252
• 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: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9855 DA