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

Model Number CLV-190

Device Problem No Display/Image (1183)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

The customer returned the device for evaluation and repair.The investigation is in process.The olympus service department evaluated the device and found the following: the rear panel was damaged and bent, the housing cover was damaged and the lamp passed a continuous test run; complaint not confirmed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus, during a colon polpectomy procedure, olympus devices malfunctioned and the intended laparoscopic procedure was converted to an open (abdominal) surgery.There was an image failure before, during and after the intended polpectomy.The image failed when extending a snare for polypectomy.The customer tried two different colonoscopes with the same light source and no image was displayed.Polypectomy could not be performed.The intended procedure was not completed and an open surgery was performed.This event includes 3 reports: (b)(6): light source, clv-190, sn: (b)(4).(b)(6): gif-h185, sn: (b)(4).(b)(6): cf-h185i, sn: (b)(4).This report is 1 of 3 for (b)(6): light source, clv-190, sn: (b)(4).

Event Description

Additional information received from the customer: the customer reported each olympus device was inspected prior to use (plugged in, light check, suction and flush or equipment, and imaging).No patient injury or harm experienced.The customer also reported additional procedures for other patients needed to be cancelled due to the equipment failure.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer, the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The subject device was returned for evaluation.The reported event of no image could not be reproduced.The rear panel suffered a blow and was bent and the housing cover suffered damage.A definitive root cause was not identified.Based on the available information, the legal manufacturer could not determine the probable cause of the image failure.The probable cause of the device damage were due to wear and tear from mishandling.Olympus will continue to monitor field performance for this device.

Event Description

Additional information received from the customer: the customer reported each olympus device was inspected prior to use (plugged in, light check, suction and flush or equipment, and imaging).No patient injury or harm experienced.The customer also reported additional procedures for other patients needed to be cancelled due to the equipment failure and some patients were seen in another hospital.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14645032
• MDR Text Key: 293645389
• Report Number: 8010047-2022-09740
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170298868
• UDI-Public: 04953170298868
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 07/06/2022; 06/09/2022
• Supplement Dates FDA Received: 08/04/2022; 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2018
• 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: GIF-H185, SN: (B)(6) ,CF-H185I, SN: (B)(6); UNKNOWN SNARE
• Patient Outcome(s): Required Intervention; Other