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

Model Number GIF-H260Z

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, due to handling (insufficient cleaning), the air and water nozzles are clogged, and the draining function reduced, bending angle insufficient due to elongation of the angle wire, play of the angle knob out of the normal state due to the elongation of the angle wire, due to the deformation of the curved tube, there was a jump during up/down direction angle operation, scratches insertion tube, curved rubber adhesive part missing, curved rubber bond cracked, curved rubber bond cracked, scratches on the curved rubber adhesive part, scratches found on the tip cover, scratches found on switch 1, air/water supply cap (water pipe) loose, scratches found on the scope connector, seal/label on the scope connector peeled off, scratches found on the operation part, scratches found on the insertion part corrugated tube oredome, scratches found on the switch box, scratches on the operation unit cover, scratches on the up/down knob, scratches on the up/down angle fixing lever, scratches found on the right/left knob, scratches found on the grip, scratches found on the universal cord, scratches found on the operation part side oredome of the universal cord, scratches on the cover case, scratches on the right/left angle fixing knob, and j seal on the scope connector peeling off.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

A user facility submitted a repair request to the olympus service center, for an evis lucera gastrointestinal videoscope exhibited image problem and air/water leakages.Upon inspection and testing of the returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer confirmed they cleaned, disinfected, and sterilized the product before sending it to olympus.The customer did not know when the foreign material adhered to the endoscope or what the foreign material is.There was no delay in the start of precleaning.There were no abnormalities in the accessories used for reprocessing.The customer flushed the air/water nozzle with water and air.The air/water nozzle was wiped/brushed with clean lint-free cloths, brushes, or sponges.The air/water nozzle was flushed with the detergent solution.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, it is likely that the foreign material remained due to not being able to be removed even if proper reprocessing was conducted because of the physical damage to the device.The foreign material was unable to be identified.The event can be prevented by following the instructions for use which state: "chapter 3 preparation and inspection 3.6 inspection of the endoscopic system.- inspection of the objective lens cleaning function 1.Keep the air/water valve¿s hole covered with your finger and depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens.2.Release the air/water valve.While observing the endoscopic image, confirm that the emission of water stops and that the valve returns smoothly to its original position.3.While observing the endoscopic image, feed air after feeding water by covering the hole in the air/water valve with your finger.Confirm that the emitted air removes the remaining".Olympus will continue to monitor field performance for this device.

Event Description

The procedure was completed with the same 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: 17317307
• MDR Text Key: 319672203
• Report Number: 9610595-2023-10065
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H260Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• 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