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

Model Number	GIF-E3
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found watertightness was lost due to a pinhole on the bending section rubber, the light guide lens had a crack, the distal end cover had a scratch, the connecting tube had a wrinkle, the connecting tube had the coating peeling, the scope cover had a scratch, the eyepiece was sticky, the suction cylinder was shaved, the universal cord was sticky, the light guide connector was sticky, the bending tube had a dent, the bending angle in the up/down/left/right directions were out of standard due to wear of the angle wire, the up/down and left/right knobs had play, the forceps could not be inserted smoothly due to a dent on the forceps passage channel, the image had a stain due to damage on the image guide bundle, the image guide bundle had significant breakage, the water supply volume did not meet standard due to clogging of the air/water tube, suction volume did not meet standard due to the suction cylinder being shaved, and illumination was poor due to breakage of the light guide bundle.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus, the gastrointestinal fiberscope had an image problem.Inspection and testing of the returned device found there was dirt on the bending section rubber, the grip, the right/left knob, and the up/down knob, which is indicative of insufficient or incorrect reprocessing.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information based on the information supplied by the customer.Please refer to the following sections for the new information: b5 - event description.
Event or Problem Description
The issue was found during reprocessing.
Additional 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 reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be prevented by following the instructions for use (ifu) which state: ifu (reprocessing manual) states if cleaning, disinfect, and sterilization of endoscope was insufficient, the device may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.All channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL FIBERSCOPE
• Common Device Name: GASTROINTESTINAL FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15782630
• Report Number: 9610595-2022-03842
• Device Sequence Number: 4897654
• Product Code: FDS
• UDI-Device Identifier: 04953170307355
• UDI-Public: 04953170307355
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIF-E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2022
• Supplement Date Received by Manufacturer: 02/09/2023; 02/15/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 02/09/2023; 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown