MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

The customer returned the clv-190 light source to olympus for evaluation.The user complaint was not confirmed.A visual inspection was performed on the returned device and no physical anomalies or irregularities were observed.The pump air pressure and activation were tested using a laboratory air pressure gauge.The air pump was toggled between on and standby, and functioned as intended.An air pump pressure check was performed and the device passed all olympus specifications.Based on the evaluation, the device passed the air pressure pump test.The low, medium and high modes measured within olympus specifications.Pump is working and fully functional.The exact cause of the reported event could not be determined.The clv-190 instruction manual warns users in section 5.9 ¿air/water feeding.¿ ¿over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation.¿.

Event Description

Olympus was informed that during three different post op evaluations, three patients experienced abdominal pain and gas due to over-inflation from the device.The user facility reported that the device had a continuous air flow, while the air function was set to standby.The patients did not require any additional treatment or hospitalization.The patients were discharged home in stable condition.In addition, it was reported that during the procedure the user facility¿s technician was able to confirm a continuous air flow after the ucr (insufflator) was powered off and the water bottle was disconnected from the side of the scope.This is 3 of 3 reports.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fdf to gct.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7627945
• MDR Text Key: 112470186
• Report Number: 2951238-2018-00360
• Device Sequence Number: 1
• Product Code: GCT
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Device Catalogue Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UCR/SN. (B)(4).