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

Model Number	CF-2T160I
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer hmi (hygiene microbiological investigation) results reported the device (all channels) tested positive with pseudomonas aeruginosa (125 cfu/100 ml) and microorganism revivable 37 degrees celsius (170 cfu/ml).The ofr (olympus france) french olympus subsidiary for hmi (hygiene microbiological investigation) results has not yet been received for evaluation.Below are information on customers cds checklist: soluscope 4 : soluscope cln / soluscope paa manual/brush- olympus bw-412t aniosyme -the detergent used for cleaning soluscope cln - the disinfectant used for disinfection.Storage : surestore.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, after a microbiological routine control test on the subject medical device as required by french regulation, the user detected an unexpected contamination.The issue found during reprocessing.The user then sent the device to the ofr (olympus france) french olympus subsidiary for hmi (hygiene microbiological investigation) for further investigation.The user did not report any contamination or any patient injury or patient infection to which this medical device could have been a contributory cause.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on results of third party testing, the device evaluation, and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.Multiple defects were noted including: insulation failure at distal end.Light guide lens cracked.Bending section rubber glue peeled off.Bending section rubber glue worn out.Insertion section bulge.Universal cord bulge.Biopsy channel worn out.However, these defects alone are not considered severe enough to cause a potential adverse event.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, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results of 1cfu/endoscope of micrococcaceae, conformed to the regulation's recommendation.The following is included in the device ifu: "warning: 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 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: 13589153
• Report Number: 8010047-2022-03483
• Device Sequence Number: 5912838
• Product Code: FDF
• UDI-Device Identifier: 04953170307645
• UDI-Public: 04953170307645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954451
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: CF-2T160I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/30/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2015
• 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