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

Model Number TJF-160VR

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Event Description

The customer reported that some of the elevator wires on his olympus evis exera duodenovideoscope were noted to be sticking up during use.Additional details relating to the patient and the event have been requested, but no response has been received at this time.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user's report was confirmed.The elevator cable was frayed and some of the wires were sticking up.Additionally, there was a gap between the light guide lens and the distal end body.The cover adhesive was gapped.Other findings include a chipped light guide lens, adhesive wear and discoloration, scratches on the insertion tubing, wear and tear on the scope connector as well as the suction cylinder.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 investigation, a definitive root cause could not be established.The suggested phenomenon of "wire is frayed and sticking up" was presumed to have been due to a fatigue-related breakdown by repeated operation of the forceps elevator.Moreover, the wire was frayed and raised from repeated brushing around the forceps elevator and attachment/detachment of the distal cover.The suggested phenomenon of "gap between lg-lens [light guide lens] and c-body [distal body cover]" was presumed to have been due to glue between these components being damaged and then the gap was generated due to physical stress/ chemical stress/ storage environment.Users can detect the suggested events properly by handling the device in accordance with the following instructions for use (ifu): "·instructions for safe use : warning : the elevator wire at the distal end is damaged (broken, frayed, or bent), the damaged elevator wire may cause injury or pose an infection control risk when detaching of the distal cover or cleaning the endoscope.In this case, carefully detach the distal cover and perform cleaning.·preparation and inspection - attaching the distal cover - when attaching the distal cover, make sure to confirm that the portion of the elevator wire at the distal end is not broken, frayed, or bent.Otherwise, the broken elevator wire may cause injury.Also, if the broken elevator wire is deformed, it may compromise patient, operator, or other medical personnel safety.·inspection of the endoscope." users can reduce/prevent the suggested event by handling the device in accordance with the following ifu: "·cleaning, disinfection and sterilization procedures - brushing around the forceps elevator and instrument channel outlet - using a stiff brush or excessive force when brushing may scratch the distal end and result in water leakage; cause the elevator wire to come off the distal end, bend or kink the elevator wire so that the forceps elevator will no longer work.·preparation and inspection - attaching the distal cover ·do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.·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.·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." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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: 13777774
• MDR Text Key: 287333156
• Report Number: 8010047-2022-04489
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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