MAUDE Adverse Event Report: ENDOCLOT PLUS CO., LTD. ENDOCLOT; ENDOCLOT SUBMUCOSAL INJECTION SYSTEM

Model Number SIS-30-01

Device Problem Material Fragmentation (1261)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

User reported that the luer lock of the sprial syringe broke off outside the patient during the procedure.The procedure was completed.

• Brand Name: ENDOCLOT
• Type of Device: ENDOCLOT SUBMUCOSAL INJECTION SYSTEM
• Manufacturer (Section D): ENDOCLOT PLUS CO., LTD.; unit 101, b8 building,; 218 xinghu st; suzhou industrial park, jiangsu 21512 3; CH 215123
• Manufacturer (Section G): ENDOCLOT PLUS CO., LTD.; CH
• Manufacturer Contact: jennifer hsu ; CH
• MDR Report Key: 16803065
• MDR Text Key: 314529349
• Report Number: 3013155768-2023-00003
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K191254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIS-30-01
• Device Catalogue Number: SIS-30-01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• 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: Initial
• Patient Sequence Number: 1