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

Model Number GIF-H170

Device Problems Device Reprocessing Problem (1091); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for inspection, and the customer's reported issue ¿cleaning brush gets caught.¿ was confirmed.The following findings were also noted during device evaluation: angulation in the up direction is out of specifications, due to the worn angle-wire, the gap on up/down knob is out of standards due to the worn angle-wire, light guide bundle is abnormal, charged coupled device (ccd) lens is broken, light guide lens is broken, connecting tube is corrugated, connecting tube protector is broken, suction cylinder is deformed, switch button 1 is cut off, there is white scratch on the image due to the broken ccd unit, and bending section glue is cracked.Due to the nature of this reportable event, the customer provided the cleaning sterilization and disinfection (cds) processes performed at the user facility.The device was cleaned, sanitized or disinfected prior to being sent for repair.The customer reported the facility does not delay the start of precleaning of the equipment after use.Customer noted normal, no abnormalities on the accessories used for reprocessing.The customer noted that the facility wipes or brushes the air and water nozzle with a gauze, brush, or sponge.The customer noted that the facility flushed the air/water nozzle with water and air.The customer noted that they flushed air/water nozzle with detergent solution.The customer reported that rethe facility brushed the instrument channel, instrument channel port, and suction cylinder.Based on the results of the investigation, it is likely that the following led to the malfunction: a definitive root cause cannot be identified for the foreign material adhering to the device.The cause of the foreign material remaining in the device from the obtained information could not be specified.The adhesion/clogging of the material to the suction cylinder was not specifically confirmed, however we confirmed non-conformities at the possible residue point.Therefore, the device did not meet the specifications nor the features.The foreign material was possibly not removed since the reprocessing was not conducted properly due to deformation of the suction cylinder.Deformation of the suction cylinder occurred.A device history review revealed the dhr of the subject device and confirmed that the device was shipped in accordance with specifications.Although non-conformity of the device was confirmed during manufacturing, it was shipped in accordance with specifications.This issue is addressed in the instructions for use (ifu): the instruction manual gif/cf-170 series operation manual chapter 3 preparation and inspection describes how to detect for the suggested event.The instruction manual gif/cf-170 series reprocessing manual chapter 5 reprocessing the endoscope describes how to prevent for the suggested event.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the gastrointestinal videoscope cleaning brush gets caught during preparation for use for an unknown diagnostic procedure.The procedure was completed using a similar device.Upon inspection and evaluation, suction cylinder has a foreign material.There was no report of patient harm or user injury associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunctions found during incoming inspection and evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17856191
• MDR Text Key: 324771292
• Report Number: 9610595-2023-14445
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2021
• 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