MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION VERSAJET; LAVAGE, JET

Model Number 66800042

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Using versajet 2 exact.During the procedure, the clear tubing that is attached to the orange key piece malfunctioned.It was leaking every where and possibly into the machine.The rep was contacted.The supply was wasted on the machine.The doctor no longer needed the versajet 2 exact.We disconnected it, mopped the floor.No patient was harmed.

• Brand Name: VERSAJET
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 13848025
• MDR Text Key: 287619750
• Report Number: 13848025
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2022

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 Operator: Health Professional
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50938702
• 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: 03/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1