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

Model Number CLV-S40PRO

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

The subject clv-s40pro was returned to omsc.However, omsc could not conduct the verification to reproduce the phenomenon with non-olympus lamp mounted in the subject clv-s40pro, because non-olympus lamp was not returned.Omsc mounted olympus lamp in the subject clv-s40pro, and confirmed the operation.Then the subject clv-s40pro was operated normally.As a result of the investigation, omsc concluded that there was no abnormality with the subject clv-s40pro and that this event was caused by using the non-olympus lamp.The clv-s40pro instruction manual states that never install a lamp that has not been approved by olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The followings were reported to olympus medical systems corp.(omsc).-after 30 minutes from starting an abdominal laparoscopic salpingo resection, the lamp in the subject clv-s40pro was broken.-the user replaced the endoscopic system including the subject clv-s40pro with the spare system, and completed the procedure.-there was no report of the patient¿s injure regarding this event.-the broken lamp was not olympus manufactured.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code.".

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7066188
• MDR Text Key: 94282317
• Report Number: 8010047-2017-01874
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CLV-S40PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2009
• 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