MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problems Microbial Contamination of Device (2303); Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the olympus local service department for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Investigation on microbial detection: nonconformity of the subject device, which may affect the reported event, was not confirmed via device inspection result of the olympus local service department.The exact cause of this event could not be conclusively determined.Investigation of dirt inside the light guide lens: olympus medical systems corp.(omsc) was informed from the olympus local service department that it was found that the subject device has water leaks, the light guide lens scratches, and the light guide lens repair adhesive wear.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred due to the following causes.- the gap occurred at the light guide lens adhesive due to influence of physical stress and dirt might enter the light guide lens from the gap.- the moisture entered the subject device and components inside the light guide lens got corroded and the corrosion product may have remained under the light guide lens as dirt.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the subject device tested positive for unspecified microbes.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the olympus local service department, it was found that inside of the light guide lens of the subject device was dirty.Other detailed information was not provided.There was no reported of patient injury associated with the event.The dates of the two events were unknown.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 13024102
• MDR Text Key: 286230473
• Report Number: 8010047-2021-16310
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1