MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE

Model Number CLV-190

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

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

Event Date 06/07/2023

Event Type  Injury  

Event Description

The customer reported to olympus that error e311 -white balance incomplete occurred on an unknown endoscope.The event occurred during the beginning of an endobronchial ultrasound bronchoscopy procedure after the patient was sedated for approximately 45 minutes and an error occurred on clv-190 and another scope was tried but the same error occurred.The power unit was turned off and on and error code e931 appeared.Two different lamps were replaced but the same issue recurred.This equipment troubleshooting led to procedural delay.The physician then canceled the procedure due to the error codes produced.Additional follow-up is being performed to determine if medical intervention was required and patient outcome due to cancelled procedure, but the information is unavailable that the time of the report.Related patient identifier # (b)(6); evis exera iii xenon light source, model number clv-190, serial # (b)(6).Related patient identifier #(b)(6); bronchoscope flexible/rigid, model name and serial # -unknown.Related patient identifier # (b)(6); bronchoscope (flexible/rigid), model name and serial # unknown.

Manufacturer Narrative

This report has been submitted by the importer under this mdr report number 2429304-2023-00214 the device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Section d-4 the device model, serial numbers are unknown, a representative device was chosen.

• Brand Name: EVIS EXERA III XENON LIGHT SOURCE
• Type of Device: XENON LIGHT SOURCE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17281040
• MDR Text Key: 318917995
• Report Number: 3002808148-2023-06842
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BRONCHOSCOPE - SN/MODEL UNK; BRONCHOSCOPE -SN/MODEL UNK; MODEL NUMBER CLV-190, SERIAL # (B)(6).
• Patient Outcome(s): Other