MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number OLYMPUS CLV-190

Device Problems Filling Problem (1233); Inflation Problem (1310)

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

Event Date 08/19/2020

Event Type  malfunction  

Event Description

We went to test scope when ultrasound machine was hooked up to the processor and the ultrasound balloon would not fill with water.The patient was already under anesthesia and all of the equipment hooked up to the processor as well as the scope was changed but the balloon would still not inflate.The processor needed to be changed out and the wires needed to be connected and that took time and biomed was called in to help.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 10689923
• MDR Text Key: 211669186
• Report Number: 10689923
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OLYMPUS CLV-190
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2020
• Date Report to Manufacturer: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA