MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GASTROINTESTINAL FIBERSCOPE

Model Number	GIF-E3
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The device was returned to olympus (b)(4).Olympus deutschland gmbh sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end and the instrument, the air/water channels of the device.The testing result cleared the german guideline.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 microbiological testing by the user facility, following microbes were detected from the sample collected from the device.Distal end: staphylococcus warneri (1 cfu) instrument channel: escherichia coli (68 cfu), pseudomonas aeruginosa (41 cfu), serratia marcescens (2 cfu) the device had been reprocessed with a steelco automated endoscope reprocessor model ew 2/2, using neodisher septo pac.There was no report of infection associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• Brand Name: GASTROINTESTINAL FIBERSCOPE
• Common Device Name: GASTROINTESTINAL FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10620155
• Report Number: 8010047-2020-07159
• Device Sequence Number: 16432225
• Product Code: FDS
• UDI-Device Identifier: 04953170307355
• UDI-Public: 04953170307355
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: No Information
• Device Model Number: GIF-E3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1