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

Model Number	PCF-H180AL
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not been returned to omsc for evaluation but was returned to olympus (b)(4).The evaluation is in progress currently.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, on jun 18th, 2021, following microbes were detected from the sample collected from the subject device.Air/water channel: xanthomonas maltophilia (1 cfu/endoscope).Auxiliary channel: xanthomonas maltophilia (1 cfu/endoscope).Instrument channel: xanthomonas maltophilia (34 cfu/endoscope).The device had been reprocessed with a non-olympus automated endoscope reprocessor, poka-yoke getinge, using peracetic acid.There was no report of infection associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from all channels of the device tested positive for coagulase negative staphylococci (2 cfu/endoscope).But the testing result cleared clear the (b)(6) guideline.(b)(4) checked the subject device and found followings; air leakage from the air/water channel, the distal end cap was scratched, the bending section rubber was worn out and discolored, the connecting tube rigidified, the angulation did not meet specification.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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
• MDR Report Key: 12133036
• Report Number: 8010047-2021-08557
• Device Sequence Number: 19776763
• Product Code: FDF
• UDI-Device Identifier: 04953170339899
• UDI-Public: 04953170339899
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1