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

Model Number TJF-260V

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

In addition to the raised wires and the gap in the adhesive on the distal end, service found that the forceps angulation and guide wire angulation were out of specification due to damage and wear of the forceps elevator wire.Angulation in the down direction was out of specification due to wear of the angle wire.The right/left angulation knob was out of specification due to a worn angle wire.The up/down knob was observed to be deformed, and there was evidence of liquid leakage in the right/left and up/down knobs due to damage.The adhesive around the lenses was worn, the light guide lens and objective lens were scratched, and white dots appeared on the image.The charge-coupled device (ccd) unit was damaged, and the scope cover was deformed.Adhesive rubber glue was chipped in the bending section of the insertion tube, and corrosion was observed at the electrical connector due to fluid ingress.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The user facility reported that during preparation for use, the forceps elevator wire was observed to be broken.There was no delay in the intended procedure and the procedure was completed using a similar device.There was no report of patient or user injury due to the event.The device was returned to an olympus service center for evaluation.Device inspection and testing found that some of the wires that compose the forceps elevator wire were raised due to being cut and frayed.Additionally, it was observed that the inside of the light guide lens was dirty due to a gap in the adhesive.This report is being submitted for the malfunctions identified during the evaluation of the device (raised wires, gap in the adhesive).

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.The device met all specifications at the time of shipment.Based on the results of the investigation, the cause of the gap in the adhesive likely occurred from physical stress, chemical stress and/or the storage environment.The cause of the raised wires likely occurred from repeated use of the device such as brushing around the forceps elevator and attaching/detaching the distal cover.The specific root cause could not be determined at this time.The following information is stated in the instructions for use which may have prevented the event: "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.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: 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.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." olympus will continue to monitor field performance for this device.

• 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: 13996590
• MDR Text Key: 298282926
• Report Number: 8010047-2022-05621
• 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: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• 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