MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA PRO XENON LIGHT SOURCE

Model Number CLV-S40PRO

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The clv-s40pro used in the referenced procedure was not returned to olympus medical systems corp.(omsc) for evaluation at this time, therefore omsc could not evaluate the clv-s40pro.The referenced clv-s40pro is scheduled to return to omsc.There were no further details provided.The exact cause of the reported event could not be conclusively determined at this time.If additional or significant information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the facility performed the holep (holmium laser enucleation of prostate) procedure.The patient had bleeding, the physician changed the procedure to turis (trans-urethral resection in saline) procedure to stop bleeding.During the procedure, the nurse and medical engineer noticed that the flame occurred for a moment.Also the drape covering the patient burnt.The procedure was completed, however the patient suffered the thermal burn on the right abdomen and inguinal area.The patient needed unscheduled hospitalization to treat the thermal burn.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2019-02169 to provide the device evaluation results.The clv-s40pro used in the referenced procedure has been returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed that there was no abnormality and/or irregularity of the exterior of the device.Also, omsc evaluated the clv-s40pro with the ancillary equipment owned by omsc and found that there was no abnormality and irregularity, and could not confirm the user¿s report.Omsc checked the device history record of the referenced clv-s40pro, there was no irregularity found.Omsc stated the cautions against the danger of fire in the instruction manual of clv-s40pro.There were no further details provided.The exact cause of the reported event could not be conclusively determined at this time.If additional or significant information becomes available at a later time, this report will be supplemented.

Manufacturer Narrative

Olympus medical systems corp.(omsc) evaluated the subject clv-s40pro in combination with the light guide which was used in the subject event and found that there was no abnormal increase in temperature on the tip of the light guide and the connection point between the light guide and the rigid endoscope.Based on the investigation results, omsc concluded that the subject clv-s40pro conformed to the specifications.The exact cause of this phenomenon could not be conclusively determined, however there was the possibility that this phenomenon was attributed to the cause except the subject clv-s40pro.Olympus stated the appropriate handling of clv-s40pro and the counter measures against abnormalities in the instruction manual of clv-s40pro.

• Brand Name: VISERA PRO 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
• MDR Report Key: 8686334
• MDR Text Key: 147570691
• Report Number: 8010047-2019-02169
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization