MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS DUODENOVIDEOSCOPE

Model Number TJF-140R

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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 8 of 51 reports.

Manufacturer Narrative

This is supplemental report to correct.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 4 of 5 reports at tjf-140r.

• Brand Name: EVIS DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 10043000
• MDR Text Key: 225598525
• Report Number: 8010047-2020-02600
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170202308
• UDI-Public: 04953170202308
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-140R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1