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

Model Number	GIF-N180
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
Event or Problem Description
The customer reported to olympus, the evis exera ii gastrointestinal videoscope tested positive for 10 colony forming unit (cfu) of mixed spp.The instrument channel was sampled.The issue was found during a routine culture of the scope.Sampling was taken at reprocessing, before use.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
Additional Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing.All channels were sampled.There was no detection of micro-organisms presents on the scope and in the channels.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.During pre-cleaning, the customer water was aspirated though the instrument/suction channel with a suction pump until the aspirated liquid became clear, forceps elevator moved to raise and lower 3 times in water during aspiration, and the auxiliary channel flushed with water.There was a less than 60 mins transition period between precleaning to manual cleaning.During manual cleaning, leak testing was performed according to the ifu.The customer used dr weigert mediclean forte detergent with channel-opening maj-1888 brush to brushed and flushed the air/water channel, instrument/suction channel, suction cylinder, instrument channel port and the auxiliary channel.In addition, the forceps elevator was operated (up/down) in the detergent solution.There was no manual disinfects of the scope performed.For automated endoscope reprocessor (aer) treatment, the getinge ew2 reprocessor along with getinge pokayoke detergent and getinge pokayoke a + b disinfectant were used.The scope was stored in a drying cabinet for 30 days with all removable parts detached and olympus provided the processing training.The scope was not sterilized.The customer stated that no automated endoscope reprocessor testing was performed.The customer suspected device was returned for investigation.Upon evaluation of the returned device the following defects were noticed: insertion tube and protector (chemical damage, delamination, surface damage, staining, buckle, sneakiness, peel-off, cuts, flexibility), and foreign material at the distal end unit due to insufficient cleaning of the scope.The faulty parts were replaced and device return to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 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 II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• 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: 13803963
• Report Number: 8010047-2022-04607
• Device Sequence Number: 20092006
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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: GIF-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2012
• 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