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

Model Number GIF-H170

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during an unspecified procedure, ¿black matter with metal pieces¿ was coming out of the working channel of the gastrointestinal videoscope.There was no patient or user harm reported due to the event.

Manufacturer Narrative

The device was returned to olympus for evaluation.During the device evaluation, the following was found: there was foreign matter found within the air/water nozzle resembling silicon or glue that was not removable, and foreign matter was found in the light guide lens from residual liquid.The grip had a scratch.The switch box had a scratch.Due to wear, the air/water cylinder, and the suction cylinder had no color.Due to damage on the channel tube, water tightness was lost.Due to clogging of the nozzle, air supply volume did not meet the standard value.Due to wear of the angle wire, the play of the up/down knob was out of the standard value.The light guide lens had foreign objects.The connecting tube had a scratch.The universal cord had a wrinkle.The video cable had a scratch.The video connector had a crack.The investigation is ongoing, and 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.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 black substance containing metal pieces attached to the working channel was unable to be identified.It was unclear whether the reprocessing was performed according to the instructions for use (ifu).There was no physical damage to the area where the foreign matter remained.It was confirmed that foreign matter was attached to/clogged the air and water nozzles, but it was not possible to identify the foreign matter.Due to a leak failure in the forceps channel, proper reprocessing may not have been possible and the foreign object may not have been removed.Dirt could be confirmed inside the light guide (lg) lens, but the dirt could not be identified.The adhesive around the lg lens has peeled off due to physical stress such as hitting the tip of the scope or dropping the tip, or chemical stress from the chemical solution used, and moisture has entered the lg lens.The detection method is described in the instruction manual gif/cf-170 series operation manual chapter 3 preparation and inspection and prevention measures are described in the instruction manual gif/cf-170 series reprocessing manual chapter 5 reprocessing the endoscope.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: 17644576
• MDR Text Key: 322208059
• Report Number: 9610595-2023-12401
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2020
• 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