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

Model Number GIF-XQ260

Device Problems Mechanical Problem (1384); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found foreign objects inside the nozzle likely due to insufficient cleaning.Additionally, due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to wear of the angle wire, the play of up/down knob was out of the standard value.The air/water cylinder had corrosion.The switch number 4 had wear.The paint on the suction cylinder was peeled.The plastic distal end, suction connector universal protector, switch box, switch number 1, forceps elevator, up/down knob, right/left knob, the adhesive around the bending section cover, and control unit were scratched.The control unit was damaged due to physical stress.The adhesive around the bending section cover had a crack.The connecting tube, control unit, right/left knob, up/down knob, forceps knob, forceps lever, and switch box had discoloration.The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure what the foreign material adhered to the scope¿s nozzle was.Additionally, it was confirmed there was no delay in the start of pre-cleaning, the customer did not confirm whether they have flushed the nozzle with water and air, there were no abnormalities in the accessories used for reprocessing.They did not confirm whether they¿ve presoaked the endoscope in detergent solution.They did not confirm whether they¿ve wiped the nozzle with clean lint-free cloths/brushes/sponges, and they flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing.The investigation is ongoing [and follow up with the user facility is currently being performed].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 remote switches issue on the evis lucera gastrointestinal videoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: nozzle had foreign objects.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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, from the information obtained the cause of the foreign material remaining in the device was unable to be specified, since whether reprocessing was practiced in accordance with instructions for use (ifu) is unknown.Therefore, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be detected and prevented by following the ifu sections: instructions for evis lucera gif/cf/pcf type 260 series, operation manual, chapter 3 ¿preparation and inspection¿ describes how to detect the subject event.Instructions for evis lucera gif/cf/pcf type 260 series, reprocessing manual, chapter 3 ¿cleaning, disinfection, and sterilization procedures¿ describes how to prevent the subject event.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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: 18522446
• MDR Text Key: 333098448
• Report Number: 9610595-2024-00996
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XQ260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2004
• 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