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

Model Number GIF-1100

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/20/2022

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, switch 2 cut, scope stopper deformed, plug unit scratched, due to wear of angle wire, bending angle in up direction did not meet the standard value, distal end cover deformed, adhesive on angle rubber cracked, connecting tube cut, and universal cord coating peeling.The faulty parts were replaced, and the device was 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 reported to olympus that the gastrointestinal videoscope had light guide lens and channel defects.Upon inspection and testing of the returned device, foreign material was found clogged in the scope instrument channel 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.

Event Description

Additional information was provided from the initial reporter.According to the initial reporter, during the procedure the glue that was used had entered the channel and covered the lens, for this reason the customer sent the device in for repair.There was no mention of any injury to patient or user.No further information was provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and additional information provided by the customer (updated b5).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 could not be determined.It was confirmed that white foreign material had adhered to the inside of the biopsy channel.Additional information was provided indicating glue had enetered the channel and covered the lens during the procedure.Therefore, it is likely the white foreign material could be glue.The cause for the foreign material remaning in the channel could not be specified.Three attempts were performed to obtain additional information regarding reprocessing, but no response was received from the customer.The event can be prevented by following the instructions for use (ifu) which state: "avoid aspirating solid matter or thick fluids; instrument channel, suction channel, or suction valve clogging can occur.If the suction valve clogs and suction cannot be stopped, disconnect the suction tube from the suction connector on the endoscope connector.Turn the suction pump off, detach the suction valve, and remove solid matter or thick fluids.If the suction valve clogs and the suction cannot be used when solid matter, such as the clip or thick fluid, are aspirated, withdraw the endoscope, and disconnect the suction tube from the suction connector on the endoscope connector.Attach a syringe containing sterile water to the suction connector.Straighten the insertion tube as much as possible and forcefully flush the connector with the water while the suction valve of the endoscope is slightly depressed.Repeat the flush until the thick fluid or solid matter are discharged from the distal end of the suction channel.After discharging, confirm that there is no irregularity in the suction function according to ¿inspection of the suction function¿ on page 50, before using the endoscope again.If the thick fluid or solid matter cannot be discharged, stop using the suction function and contact olympus." 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: 16018442
• MDR Text Key: 308534128
• Report Number: 9610595-2022-05807
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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