MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS IRRIGATOR / FLUSHER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number AFU-100

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/27/2021

Event Type  malfunction  

Event Description

Irrigator (flusher), olympus leaked water during egd in endo suite # 2.

• Brand Name: OLYMPUS IRRIGATOR / FLUSHER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 11930043
• MDR Text Key: 254587326
• Report Number: MW5101692
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AFU-100
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other