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

Model Number GIF-1200N

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 and the air/water nozzle was flushed with air/water.Information on manual cleaning: the accessories used for reprocessing were normal.Liquid was sent to the air/water nozzle and flushed with detergent solution.The scope was flushed with detergent solution.The scope 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, play of the angle knob is out of the normal state due to the elongation of the angle wire, curved rubber scratches, scratches on the curved rubber adhesive part, foreign object inside the nozzle, and scratches found on the scope connector.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 a gastrointestinal videoscope, having bending angle insufficient due to the elongation of the angle wire.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 root cause of the event was unable to be identified.The foreign material was unable to be identified.It was confirmed that there was no deformation of the air/water nozzle and there were no obvious deviations in reprocessing.The inspection method for the event is described as follows in the instructions for use "chapter 3 preparation and inspection, section 3.3 inspection of the endoscope and section 3.8 inspection of the endoscopic system¿ as below.[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 water feeding function] 1.Keep the air/water valve¿s hole covered with your finger.2.Depress the valve.Observe the endoscopic image and confirm that water flows on the entire objective lens." 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: 17101189
• MDR Text Key: 317497885
• Report Number: 9610595-2023-08689
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1200N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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