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

Model Number TJF-Q180V

Device Problems Crack (1135); Leak/Splash (1354); Loose or Intermittent Connection (1371); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated at olympus (b)(6).The customer reported issue was confirmed.Inspection found leakage between the device handles and terminal along with the cover.Loose handles were observed.Peeling at the ¿rubber¿ bending section was found and noted to be discolored.The insertion tube was observed to be crumpled and wrinkled all throughout.The lens were observed to be corroded.Based on evaluation findings the failures observed could be attributed to use handling and or maintenance issue.Investigation is ongoing.This report will be supplemented according following investigations.

Event Description

It was reported that the device angulation is loose.The issue occurred during an unknown procedure.There are no reports of patient harm.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: b5, e1,g3, g6, h2, h6 and h10.

Event Description

Leakage between the handles, leakage between the terminal and the cover, loose handles, rubber glue peeling and discolored, insertion tube crumpled and wrinkled throughout its length, internally corroded light lens were reported on the device.The issue found during the cleaning process, reprocessing.There was no patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, the cause of this event cannot be conclusively specified.Based on device evaluation findings, it was presumed that gap generated at the lg lens glue, and the underside of the lg lens became dirty.·device inspection result shows dirt under the lg lens.·device inspection result shows white discoloration at the lg lens glue, which is evidence of chemical stress.·ifu (instruction for use) cautions about chemical stress and storage environment.The user can reduce/prevent the occurrence of the event by handling the device in accordance with the following ifu statement; as stated on the ifu the user manual states: precautions_ warning: important information ·precautions: this instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions.For information on the durability against each method, please contact olympus.If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician.Do not use if any abnormality is found.Storage and disposal warning: the storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Do not store the endoscope in direct sunlight, at high temperature, in high humidity, or exposed to x-rays and/or ultraviolet-rays.Doing so could damage the endoscope or pose an infection control risk.·storage of the endoscope confirm that all surfaces of the endoscope (especially the interior of the channels, the distal end, the lens, and the electrical contacts) are completely dry.Olympus will continue to monitor complaints for this device.

• Brand Name: EVIS EXERA II 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
• MDR Report Key: 11995922
• MDR Text Key: 273305220
• Report Number: 8010047-2021-07497
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1