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

Model Number GIF-Q150

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 was confirmed.The device evaluation found wrinkles on the connecting tube, low angulation in all directions, and free play due to deformation of the bending tube.Additionally, the adhesive around the objective lens, light guide lens, bending section cover, control knob, and nozzle had foreign material.Dent marks on the light guide cover glass.The suction cylinder was shaved off.Scratches on the grip, scope cover, control unit, switches number 1 and 4.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

An olympus field service engineer reported on behalf of the customer, reduced angulation in up/down direction and wrinkles on the insertion tube on the gastrointestinal videoscope.The issue was found during an unspecified procedure.There were no reports of patient or user harm associated with this event.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: nozzle has foreign objects.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.The customer answered the following: was the device was reprocessed at the customer site? yes.Has the device been used to a patient with foreign material attached to the device: there is a possibility.Do you perform pre-clean steps without any delay? there is a possibility that sufficient brushing could not be performed.The device was not correctly reprocessed at the time of pickup of the device for inspection.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 since reprocessing was not conducted properly due to dented plastic distal end cover / peeled bending section cover glue.The foreign material was unable to be identified.The event can be prevented by following the instructions for use (ifu): detection methods are written in ifu: gif-q150 operation manual chapter 3 preparation and inspection.Prevention measures are written in ifu: gif-q150 reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18084972
• MDR Text Key: 327540940
• Report Number: 9610595-2023-16618
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170229435
• UDI-Public: 04953170229435
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051645
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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