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

Model Number GIF-Q260J

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

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

Event Type  malfunction  

Manufacturer Narrative

The device was cleaned, disinfected, and sterilized before requesting repair.The presence of foreign material adhering to the device was not known.Pre-cleaning information: there was no delay to the start of pre-cleaning which was done properly.The air/water nozzle was flushed with air/water and detergent solution.Information on manual cleaning: the accessories used for reprocessing were normal and without issues.Liquid was sent to the air/water nozzle.The air/water nozzle was wiped/brushed with clean lint free brush/cloth/sponges.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 wear of angle wire, bending angle in up direction did not meet the standard value, nozzle had foreign objects, due to wear of angle wire, the play of up/down knob out of the standard value, adhesive on angle rubber chipped, adhesive on angle rubber cracked, adhesive on angle rubber has white-clouded area, due to clogging of nozzle, water removal ability did not meet the standard value, bending tube deformed, mouthpiece loose, universal cord wrinkled, switch 1 scratched/worn, protector of universal cord on scope connector side scratched, objective lens cracked, distal end over scratched, and connecting tube scratched.The faulty parts will be replaced, and the device will be returned to the user facility.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 videoscop, having insufficient angle.Upon inspection and testing of the returned device, foreign material was found clogged in the scope 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.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 foreign material could not be identified nor the root cause of it.The event can be detected/prevented by following the inspection method for the event is described as follows in the operation manual: ¿chapter 3 preparation and inspection, section 3.2 inspection of the endoscope and section 3.6 inspection of the endoscopic system¿ "[inspection of the endoscope] 9.Inspect the air/water nozzle at the distal end of the endoscope for any irregularities such as abnormal swelling, bulges, and dents.[inspection of the objective lens cleaning function] inspection of the spray valve function 1.While covering the spray valve hole with your finger, depress the valve all the way (till the 2nd step) and confirm that water flow is observed in the entire endoscopic image.2.While keeping the spray valve hole covered, depress the valve till the first stop position (till the 1st step) and confirm that emission of water spray is observed in the entire endoscopic image." 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: 16821035
• MDR Text Key: 314079014
• Report Number: 9610595-2023-06778
• 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: 06/07/2023

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: GIF-Q260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• 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