MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA EVIS EXERA II XENON LIGHT SOURCE

Model Number CLV-180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 11/09/2022

Event Type  Injury  

Event Description

The customer reports after a colonoscopy procedure using an evis exera ii colonovideoscope and an evis exera ii xenon light source, overnight, the patient developed a perforation.The scope did not malfunction in any way during the procedure.No endo therapy devices were used in the procedure.To treat the bowel perforation, the patient had a surgical bowel resection and hospitalization.The patient's current condition is reported as "stable at time of last conversation." case with patient identifier (b)(6) reports the xenon light source used in the procedure.Case with patient identifier (b)(6) reports the colonoscope used in the procedure.

• Brand Name: EVIS EXERA II XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA; 3-1 okamiyama, odakura; nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• MDR Report Key: 15948736
• MDR Text Key: 305145508
• Report Number: 2429304-2022-00162
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170215544
• UDI-Public: 04953170215544
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/10/2022,12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CF-H180AL
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 50 KG