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

Model Number GIF-XP260NS

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 customer's allegation of ¿reduced angulation¿ was confirmed.The device evaluation found 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.Additionally, the air/water cylinder had foreign objects due to insufficient cleaning.Due to clogging of nozzle, water removal ability did not meet the standard value.The bending section cover had white-clouded area.The mouthpiece was loose, due to rotation stress of the water supply connector when attached to the scope connector.The adhesive around the light guide was peeled.The connecting tube had a scratch and 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 and air/water cylinder was.Additionally, it was confirmed there was a delay in the start of pre-cleaning, the customer flushed the nozzle with water and air, there were no abnormalities in the accessories used for reprocessing.They confirmed they did not presoaked the endoscope in detergent solution, they 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.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 reduced angulation on the evis lucera gastrointestinal videoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: air/water cylinder 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, the defects found during evaluation were confirmed, the foreign material in the nozzle could not be specified, there was no physical damage where the foreign material was found, and there were no reported reprocessing deviations from the ifu.A definitive root cause of the foreign material in the nozzle could not be identified.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) gif/cf/pcf-260 series operation manual chapter 3 preparation and inspection.Gif/cf/pcf-260 series reprocessing manual chapter 5 reprocessing the endoscope 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: 18100080
• MDR Text Key: 329125103
• Report Number: 9610595-2023-16787
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-XP260NS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2011
• 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