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

Model Number	GIF-XP150N
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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, due to deformation of scope connector, and up/down knob water tightness was lost, adhesive around objective lens chipped, adhesive on bending section rubber cracked, on bending section rubber discolored, connecting tube buckled, universal cord scratched, control unit dirty, due to wear of angle wire, the play of up/down and right/left knob out of the standard value, due to nozzle clogging, amount of water contact did not meet the standard value, and due to clogging of nozzle, water removal ability did not meet the standard value.The faulty part was 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 or Problem Description
A user facility returned the olympus asset, gastrointestinal videoscope to the olympus service center.Upon inspection and testing of the returned device, foreign material was found clogged in the scope nozzle.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no user issue reported by customer.There was no patient involvement, or user injury associated with this event.
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 device handling and insufficient or incorrect reprocessing.The event can be detected/prevented by following the instructions for use (ifu) which state: operation manual_ preparation and inspection.Inspection of the endoscope_ inspect the air/water nozzle at the distal end of the endoscope¿s insertion section for abnormal swelling, bulges, dents, or other irregularities.Operation manual_ inspection of the endoscopic system.Inspection of the air-feeding function.Inspection of the objective lens cleaning function¿.The event can be prevented by following the instructions for use (ifu) which state: reprocessing manual_ cleaning, disinfection and sterilization procedures.Precleaning_ warning: ¿if the endoscope is not immediately cleaned after each procedure, residual organic debris will begin to solidify, and it may be difficult to effectively reprocess the endoscope.¿ "flush water and air into the air/water channel_ caution: to prevent clogging of the air/water nozzle, always use the aw channel cleaning adapter to clean the air/water channel after each use.¿ cleaning, disinfection and sterilization procedures_ manual cleaning.¿flushing detergent solution into the air/water channels¿."removing detergent solution from all channels¿."presoak for excessive bleeding and/or delayed reprocessing after each procedure¿ caution: ¿follow the steps below only in cases of excessive bleeding and/or delayed reprocessing; unnecessary immersions should be avoided.Consecutive reprocessing sessions using extended immersion may damage the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• 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: 15048010
• Report Number: 9610595-2022-00067
• Device Sequence Number: 17487055
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2010
• 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