MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA 4K UHD XENON LIGHT SOURCE

Model Number CLV-S400

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

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 11/08/2021

Event Type  Injury  

Manufacturer Narrative

This event has been reported by the importer on mdr#2951238-2021-00450.The device has not been returned.The investigation is in process.The customer also stated the olympus representative would come in the mornings to check the laparoscopy equipment, turn everything on, and place the light source box on standby.This prevents the light source to go on full illumination when they plug in the light cord.The customer understands their responsibility for managing the equipment set-up however they have gotten used to this level of service.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus a patient suffered a burn from the subject device at the beginning of a procedure.During set-up for an unspecified laparoscopic case, after the drapes were placed, the surgeon took the light cord and handed it to the circulating rn to connect the light source.The light source was connected and it automatically turned on.While the nurse was connecting the other tubing and continuing with set up, the surgeon was holding the light source while turned on and laid the light cord on the patient's abdomen.It was then noticed there was a 2nd degree burn on the patient's skin.The burn was incorporated into the patient's incision.The customer reported another light source was used however it is unclear why.The procedure was successfully completed.

Manufacturer Narrative

This supplemental report is being submitted to provide 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.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to misuse of the user.The customer reported no abnormality iwith the device inspection before the procedure.As stated in the instructions for use, this event could have been prevented: do not touch the light guide connector tip of the endoscope immediately after removing from this product, both ends of the light guide cable, or the output connector of this product.It is very hot and may cause burns.Do not allow the endoscope or light guide cable tip with light to come into contact with combustible objects such as the human body or surgical drapes.Lighting can burn patients and users, burn combustibles, and lead to fire.

Manufacturer Narrative

This supplemental report is being submitted to correct the initial mdr aware date.G3: (b)(6) 2021.

• Brand Name: VISERA 4K UHD 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: 12978916
• MDR Text Key: 284303594
• Report Number: 8010047-2021-15904
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170374579
• UDI-Public: 04953170374579
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AWA03310A, UNKNOWN SERIAL.
• Patient Outcome(s): Other