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

Model Number GIF-XZ1200

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 customer suspected device was returned for investigation.Upon evaluation of the returned device the following defects were found, curved rubber adhesive missing, curved rubber bond cracked due to external factors, air and water nozzles clogged and draining function reduced, foreign object inside the nozzle, scratches found on switch 2, scratches found on the switch box, bending angle insufficient due to the elongation of the angle wire, strange noise from the up/down knob, scratches on the up/down knob, scratches on the up/down angle fixing lever, scratches on the right/left angle fixing, scratches on the insertion tube, scratches found on the operation part, scratches found on the tip cover, scratches found on the insertion part corrugated tube oredome, scratches on the operation unit cover, scratches are found on the right/left knob, scratches found on the grip, discoloration of the grip part, scratches found on the universal cord, scratches found on the operation part side oredome of the universal cord part, scratches found on the scope connector, and scratches on the scope connector cover.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 returned the olympus asset, gastrointestinal videoscope to the olympus service center.Upon inspection and testing of the customer 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 patient involvement reported with this event.

Manufacturer Narrative

The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.There was no delay in the start of precleaning.During precleaning the scope insertion section was wiped, and instrument/suction channel aspirated with water.The scope air/water channel was also flushed with air and water.During manual cleaning there was unknown if abnormalities in the accessories used for cleaning.The scope was immersed in detergent solution, but it is unknown if all external surfaces were wiped/brushed with clean lint free cloths/brushes.All channels were brushed and flushed with the detergent solution.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and good faith efforts.Updated fields: h6 and h10.The h6 "investigation type" was updated to include "communication/interviews" based on information available at the time of the follow-up submission.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the foreign matter could not be identified.A definitive root cause could not be established.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: - gif-xz1200 operation chapter 3 preparation and inspection describes the detection method.- gif-xz1200 cleaning/disinfection/sterilization chapter 5 reprocessing of endoscopes describes preventive measures.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: 17597235
• MDR Text Key: 321669883
• Report Number: 9610595-2023-12033
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2023

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-XZ1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/07/2023; 08/30/2023
• Supplement Dates FDA Received: 08/22/2023; 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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