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

Model Number	CF-Q145I
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
The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled ¿microbiological surveillance of endoscopes and implications for current reprocessing procedures adopted by an italian teaching hospital¿.The literature reported the result of the microbiological test using olympus endoscope and non-olympus endoscope from january 2014 to january 2015.As a result of the microbiological testing, the following microbes were detected.Broncho-faryngo-laryngoscopes: pseudomonas aeruginosa (1 scope), other gram-negative nonfermentant (2 scopes) and staphylococcus aureus (1 scope).Gastro-duodenoscopes: klebsiella pneumoniae (7 scopes), escherichia coli (10 scopes), other enterobatteriaceae (2 scopes), pseudomonas aeruginosa (6 scopes) and other gram-negative nonfermentant (3 scopes).Colonoscopes: klebsiella pneumoniae (5 scopes), escherichia coli (7 scopes), other enterobatteriaceae (3 scopes), pseudomonas aeruginosa (1 scope) and other gram-negative nonfermentant (3 scopes).There was no report of infection associated with this report.Based on the available information, other detailed information such as the number of microbes and the model name were not provided.Therefore, omsc will submit 51 medical device reports (mdr) depending on the number of endoscopes.This report is 43 of 51 reports.
Additional Manufacturer Narrative
This is supplemental report to correct sections "d1", "d2" and "d4".Also this supplemental report is being submitted for additional information.Olympus medical systems corp.(omsc) obtained the details of the endoscopes referring in the literature from the author as follows.The following models had positive microbiological test results; enf-xp (1 scopes); bf-pe2 (1 scopes); tjf-140r (5 scopes); gif-xtq160 (1 scopes); gif-q165 (11 scopes); gif-q160z (1 scopes); gif-v2 (1 scopes); gif-xq140 (1 scopes); gif-q145 (2 scopes); tjf-160vr (1 scopes); cf-q145l (5 scopes); cf-q165l (2 scopes); cf-q160zi (2 scopes); pcf-q180ai (1 scopes); cf-q145i (1 scopes); cf-h180al (1 scopes); non-olympus endoscope (14 scopes).This report is 1 of 1 report at cf-q145i.

• 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
• MDR Report Key: 10047486
• Report Number: 8010047-2020-02661
• Device Sequence Number: 2743189
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K131780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2020

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: CF-Q145I
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1