MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H290

Device Problems Break (1069); Detachment of Device or Device Component (2907); Failure to Clean Adequately (4048)

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

Event Date 10/15/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.A comprehensive leakage check was completed prior to technical evaluation and no leaks were found.A full technical evaluation revealed an uneven edge in the distal end adhesive.The scope was inspected immediately upon arrival from the customer.The channel was brushed with no evidence of tissue like substance.The scope was leak tested and all the channels were flushed with water with no evidence of tissue like substance.Technical evaluation has not confirmed the fault.The tissue like substance was not evident during investigation.The suggested root cause is most likely due to user handling and the cleaning process.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that after they pushed down the biopsy forceps into the evis lucera elite gastrointestinal videoscope, tissue like substance came out at the tip, and they were worried it was tissue left behind.The issue was observed during a gastroscopy procedure.A misdiagnosis and retrieval of broken parts from the patient were also reported.The procedure was completed using the same device after an unknown delay.There was no further harm or user injury reported due to the event.The customer indicated that the device went through the washer before and was also inspected prior to the procedure without any issues.Additional information is being requested to clarify the event details but no further information was received at this time.

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.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, foreign material in the biopsy channel was not confirmed.Therefore, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: operation manual: chapter 3: preparation and inspection (detection method).Reprocessing manual: chapter 5: reprocessing the endoscope (preventative measures).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 18107676
• MDR Text Key: 327869396
• Report Number: 9610595-2023-16867
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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
• Patient Outcome(s): Required Intervention