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

Model Number	GIF-2TH180
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
As reported, the endoscope failed the hygiene test despite multiple cleanings (manual and mechanical).The customer then sent the device to rrc (regional repair center) olympus hamburg for further investigation.The customer 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
The customer hygiene results below , the device tested with the following microorganism: biopsy channel yellow- staphylococcus sp.(kein s.Aureus), micrococcus sp.3 cfu/ml.Jet channel ¿ micrococci 53 cfu(s)/ml.Jet channel- staphylococcus sp.(kein s.Aureus), micrococcus sp.11 cfu/ml.Below are information on customers cds checklist: aer/ewd reprocessor: model name: etd3 and edt4.Detergent name: olympus endodet disinfectant.Disinfectant name: olympusendodis.Pre-cleaning: a/w channel, auxiliary water channel.Detergent used : descoton extra 1 %.Manual cleaning : descoton extra 1%.Brush points: instrument / suction channel , suction cylinder , instrument channel port, distal end areas around elevator.The olympus hmi (hygiene microbiological investigation) results has not yet been received for evaluation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, third party testing, and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.Olympus sent the subject device to a third party for culture testing where: sampling from: all channels; cfu: 0cfu; bacterial identification: n/a.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: 14032022
• Report Number: 8010047-2022-05860
• Device Sequence Number: 4610091
• Product Code: FDS
• UDI-Device Identifier: 04953170275463
• UDI-Public: 04953170275463
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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-2TH180
• 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: 03/13/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2013
• 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