MAUDE Adverse Event Report: MICRO-TECH(NANJING) CO.,LTD. ENDOINK ENDOSCOPIC MAKER; 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  

Manufacturer Narrative

The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The products released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.However, the incident investigation is ongoing.A follow-up report will be filed following the completion of the incident investigation.

Event Description

On july 8, 2022.Micro-tech received a 3500a report notification from fda.Report number:(b)(4).It was reported that endoink luer cap would not stay attached to syringe.New device obtained and case continued without incident.Unfortunately device and packaging discarded during case.

Manufacturer Narrative

1.Describe the event: endoink luer cap would not stay attached to syringe.New device obtained and case continued without incident.Unfortunately device and packaging discarded during case.The customer did not provide the picture of the complaint, and we combined the historic complaints for analysis.2.Cause analysis: information provided based on historical customer complaints, the customer connects the needle to endoink syringe.After turning the handle, the luer lock spins and can move up and down leaving a gap between the attachment and the syringe.This is caused by too much force when installing the injection needle.We speculated that the doctor used too much force to remove the syringe cap and the syringe cap & the luer joint were removed from the syringe 3.The correct way to use we recommend: take out the syringe, unscrew the guard cap of the syringe, gently rotate the luer joint of the injection needle and the luer joint of the syringe, and stop rotating when the force becomes obviously large.4.In order to better enhance the user experience.Optimized syringe luer, endoink has switched pre-filled syringe.This improvement can prevent such problems from happening again.We will continue to monitor to make sure this issue is closed.

• Brand Name: ENDOINK ENDOSCOPIC MAKER
• Type of Device: MARKER, COLON
• Manufacturer (Section D): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer (Section G): MICRO-TECH(NANJING) CO.,LTD.; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003 2; CH 210032
• Manufacturer Contact: becky li ; no.10 gaoke third road; nanjing national hi-tech, indu; nanjing, jiangsu 21003-2 ; CH 210032
• MDR Report Key: 15037679
• MDR Text Key: 296088664
• Report Number: 3004837686-2022-00006
• Device Sequence Number: 1
• Product Code: NBG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR