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

Model Number	PCF-PH190L
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During an onsite observation, the olympus representative attempted to issue correct reprocessing instructions to which the technician was not receptive.The olympus representative also attempted to explain olympus endoscopy support specialist (ess) functions and the intended education; however, the technician proceeded to deviate from instruction for use (ifu).The olympus representative advised the nurse manager of the findings and observations and discussed future in-services and education for the staff.The customer was receptive of the changes that need to be made.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the customer deviated from the instructions for use (ifu) for the colonovideoscope during reprocessing of the device on multiple occasions.There were no reports of patient harm or patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields to h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Upon observation on site by a field service engineer, a particular reprocessing technician was observed to have deviated from the instructions for use (ifu) on multiple occasions.Wiping of external components of scope was not compliant with the ifu.Leak testing was done incorrectly (distal end was angulated with knobs in the locked position and scope was not properly pressurized/depressurized).Brushing was done incorrectly and only done through the instrument channel.In addition to ifu deviations, care and handling practices could be improved.It was observed that distal end was hit on hard surfaces and scopes were tossed and stacked.Nurse manager was advised of findings and observations and discussed future in-services and education for the whole staff.The event can be detected and prevented by following the instructions for use: warns on inappropriate reprocessing as follows: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.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: 18972546
• Report Number: 9610595-2024-06322
• Device Sequence Number: 6666051
• Product Code: FDF
• UDI-Device Identifier: 04953170436697
• UDI-Public: 04953170436697
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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-PH190L
• Was Device Available for Evaluation?: No
• 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: 03/12/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2016
• 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