MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE

Model Number	PCF-Q180AI
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the olympus service center, the customer¿s issue was confirmed.There was a visible shadow in the charge-coupled device (ccd) image.The ccd lens and light guide lens was cracked.The glue was porous around the lenses.The bending section was deformed, and the connecting tube was buckled.The s-cover unit color ring was cracked.The biopsy port had corrosion.The universal cord was deformed and squeezed, and the bending section cover glue was cracked.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.The contact person/ occupation of the reporter is unknown.A supplemental report will be submitted should additional information be made available.Date of event ¿ (b)(6) 2021.
Event or Problem Description
It was reported by the customer, the infected (unwashed) evis exera ii colonovideoscope presented a black strip in the image.No patient harm reported.Olympus sent the device to an independent laboratory for culture testing.The auxiliary water channel tested positive for one (1) colony forming unit (cfu) of staphylococcus warneri.The scope was sampled again which resulted in a negative test.This report is to capture the reportable malfunction of the positive culture.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The cause of the event could not be identified.The relationship between the event and device could not be determined from the following: · no abnormality was confirmed in the inspection related to the customer's indication.· the equipment was not cleaned at the facility.· as a result of bacterial culture in the first sample, bacterial growth was observed.· as a result of bacterial culture in the second sample, no bacteria were detected.The instructions for use (ifu) provides the following guidelines: reprocessing manual: 1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Common Device Name: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12712463
• Report Number: 8010047-2021-13755
• Device Sequence Number: 4774830
• Product Code: FDF
• UDI-Device Identifier: 04953170339172
• UDI-Public: 04953170339172
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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-Q180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2005
• 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