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

Model Number TJF-260V

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

In addition to frayed and raised k-wire, service found there was a leakage due to deformation of the right/left knob, there was a leakage due to deformation of the up/down knob, there was a white dot on the screen due to damaged charge-coupled device, the light guide lens was broken, the connecting tube was wrinkled, the scope connector was corroded, the adhesive on the distal end was worn, and the adhesive on the bending section cover was broken.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported while preparing the subject device for use during an unspecified procedure, the forceps elevator wire (k-wire) was found to be frayed and raised.There was no patient/user harm or injury reported due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the user facility.

Event Description

Additional information received from the user facility: the intended procedure was successfully completed using a similar device.

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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to strand was cut due to fatigue breakdown by repeated operation of the forceps elevator.Moreover, knob wire (k-wire) frayed and raised by repeated brushing around the forceps elevator and attachment/detachment of the distal cover.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ ¿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¿ 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: 14549106
• MDR Text Key: 300720216
• Report Number: 8010047-2022-09125
• 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,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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: 05/03/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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