MAUDE Adverse Event Report: OLYMPUS AMERICA, INC EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

Device Problems Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)

Patient Problems Adult Respiratory Distress Syndrome (1696); Aspiration/Inhalation (1725)

Event Date 01/27/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the evis exera iii xenon light source received a communication error/screen goes to black and white specks, b30 error during a therapeutic colonoscopy procedure.The patient was under (monitored anesthesia care) mac anesthesia at the time of malfunction.The procedure time was extended and completed using the same set of equipment.Additional information was later received from the customer.A 30-minute procedural delay was reported.The patient had a possible respiratory aspiration and was subsequently placed on a bipap machine for respiratory distress.There was no further endoscopy treatment required.The date of january 27, 2023, reflected on f13 is when olympus became aware of a reportable malfunction.The date of march 06, 2023, reflected on f6 is when olympus became aware of a serious injury through additional information received from the customer.This importer medwatch is being submitted for the serious injury reported by the customer.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 16686619
• MDR Text Key: 312758735
• Report Number: 2429304-2023-00057
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2023,04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention