MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA ELITE XENON LIGHT SOURCE; ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM

Model Number CLV-S190

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the legal manufacturer investigation has been completed along with 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 device was evaluated and no device problems were found.A definitive root cause was not identified.The instructions for use include the following to prevent the reported event: system chart: the recommended combinations of equipment and accessories that can be used with the light source are listed below.New products released after the introduction of the light source may also be compatible for use in combination with the light source.For further details, contact olympus.Warning: if combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.

Event Description

The customer reported to olympus during a therapeutic bilateral subcutaneous mastectomy with prosthesis implant procedure, a patient was injured after a non-olympus device was connected to the olympus device light source with the brightness set at the maximum setting.The patient was burned due to the high temperature between the upper sternum and lower clavicle.An image was provided an shows an approximate area of 3 inch by 2 inch area of redness with a 2 mm circle area of broken (open) skin, pinkish.Ointment was applied to the burn area.The procedure was completed with another device.The customer suspected the brightness of the olympus light source was too high and burned the customer.The non olympus device connected was a hook made by (b)(4) no additional information is available at this time.

• Brand Name: VISERA ELITE XENON LIGHT SOURCE
• Type of Device: ENDOSCOPE, ACCESSORIES, NARROW BAND SPECTRUM
• 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: 13588719
• MDR Text Key: 287927349
• Report Number: 8010047-2022-03472
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170301995
• UDI-Public: 04953170301995
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111425
• 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
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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