MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

E2 marked in error.In addition to the phenomena identified in b5, the following phenomena were also identified during evaluation: the inside of the light guide lens was cracked, the connecting tube had wrinkles, the distal sheath adhesive was cracked, the light guide lens was broken, the charged coupled device lens had scratches, the up/down knob tension was out of standards due to the worn angle-wire, the up/down knob was not fixed due to deformed forceps elevator lever, the electrical connector was corroded, the scope cover was deformed, and there was an angulation malfunction in the up direction due to the worn angle-wire.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the flex video scope had a crack in the distal end.The issue was found during preparation for use for an unknown diagnostic procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information including new device evaluation information and the legal manufacturer's final investigation.On 10jan2024, further device evaluation identified that the inside of the light guide lens was discolored.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Issue 1 (distal end was cracked) ¿ based on the results of the investigation, as other damage was identified during the evaluation (including a crack in the distal sheath glue and breakage of the light guide lens and cover), this is consistent with having been cause by physical stress.However, specific root cause cannot be determined for the damage.Issue 2 (inside of light guide lens discolored) ¿ based on the results of the investigation and the information provided, it could not be determined what the foreign material was.Since the material did not adhere to the outer surface of the scope, the material would not have been removed by reprocessing.As light guide lens damage was identified during the evaluation, it is possible that humidity invaded the light guide lens leading to corrosion/discoloration.However, a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use: the operation manual, preparation and inspection chapter, inspection of the endoscope section, states in part: inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Additionally, the following is provided: warning: 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18493549
• MDR Text Key: 332671560
• Report Number: 9610595-2024-00714
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2018
• 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