MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number	PCF-H190I
Medical Device Problem Code	Communication or Transmission Problem (2896)
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.The device evaluation found due to corrosion on plug unit, e315 error (incompatible scope) occurred.In addition, the evaluation found: the universal cord, the outside shield unit, the plug unit, the cable unit, the circuit board unit in the suction connector, the micro connector unit in the suction connector, the scope connector case unit, the scope cover unit, the switch flexible printed circuit were corroded due to water leakage.The objective lens, the grip, the scope cover and the flexibility adjustment ring were scratched; the adhesive around the light guide lens and the objective lens had corrosion; the suction cylinder and the air/water cylinder had no color; the free-engage knob had discoloration; the connecting tube had coating peeling; the adhesive on the bending section cover was detached; the light guide lens had a crack; the switch 1 had a pinhole; the probe cover had a dent; due to wear of the angle wire, the bending angle in up direction did not meet the standard value; due to discoloration of the light guide bundle, the light guide rod gets warm and due to dirt on the light guide-cover glass and the light guide rod, illumination was poor.The investigation is ongoing and follow up with the user facility is currently being performed.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
The customer reported to olympus, the colonovideoscope had e315 error (incompatible scope).There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h6 a review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issues was identified.Based on the results of the investigation a definitive root cause could not be determined.However, is likely that e315 error (incompatible scope) was due to water invasion of scope connector.The event can be prevented by following the instructions for use which state: 3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5.''troubleshooting''.If the endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ''returning the endoscope for repair''.Warning: using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.5.1 troubleshooting if any irregularity is observed during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope and solve the problem as described in section 5.2, ¿troubleshooting guide¿.If the problem still cannot be resolved, send the endoscope to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Also, should any irregularity be observed while using the endoscope, stop using it immediately and withdraw the endoscope from the patient as described section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Warning: using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• 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: 18489258
• Report Number: 9610595-2024-00660
• Device Sequence Number: 15201423
• Product Code: FDF
• UDI-Device Identifier: 04953170436673
• UDI-Public: 04953170436673
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131780
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: PCF-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2018
• 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