MAUDE Adverse Event Report: ENDOCLOT; SUBMUCOSAL INJECTION SYSTEM

Model Number SIS-15-01

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The user reported that the syringe of sis-15-01 distal portion broke off and the technician was sprayed with the fluid.Injury was not reported.

• Brand Name: ENDOCLOT
• Type of Device: SUBMUCOSAL INJECTION SYSTEM
• MDR Report Key: 16803061
• MDR Text Key: 313905760
• Report Number: 3013155768-2023-00005
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SIS-15-01
• Device Catalogue Number: SIS-15-01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Patient Sequence Number: 1