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

Model Number CLV-190

Device Problems Optical Problem (3001); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The customer¿s complaint was confirmed.A bad scope socket and scope detector were noted.The unit¿s lamp life was noted to have more than 500 hours.The cause of the component failure cannot be determined at this time.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.The cause of the physical damage cannot be determined at this time.The investigation of this event is ongoing and if additional information is received this report will be supplemented accordingly.

Event Description

The service center was informed that during preparation for use, the customer plugged in the surgical endoscopes the metal housing collar was drooping or loose and not holding the endoscopes tightly enough causing the high intensity switch to disengage.Also, causing loss of light to the cases.There was no patient injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, wearing deterioration of the scope socket allowed the scope to loosen, to come off easily, or failed to detect in long-term repeated use of the device.It has been more than 8 years since the subject device was manufactured.

• 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
• MDR Report Key: 11691260
• MDR Text Key: 268502906
• Report Number: 8010047-2021-05116
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170304835
• UDI-Public: 04953170304835
• Combination Product (y/n): N
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/23/2021

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-190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1