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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III COLONOVIDEOSCOPE Back to Search Results
Model Number CF-HQ190L
Device Problems Device Reprocessing Problem (1091); Crack (1135); Scratched Material (3020); Material Split, Cut or Torn (4008)
Patient Problem Bacterial Infection (1735)
Event Date 06/28/2021
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report was returned to olympus for culturing by a third party laboratory and for physical evaluation after culturing and eo sterilization.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the user's experience cannot be determined at this time.Physical evaluation of the complaint device reveals: olympus performed a visual inspection on the received condition and discovered stains inside of the biopsy channel.The biopsy channel was inspected with an olympus boroscope and stains were located within the control body section of the biopsy channel.Additionally, scrape marks were found throughout the biopsy channel, and a tear mark was located near the middle section of the channel.The suction channel was also inspected with the boroscope and a kink was located at the opening, near the connector side.The complaint device passed the cosmo leak test (+.4).The video scope was previously refurbished on september 23rd, 2020.Third party lab culture results: areas of the scope that were cultured by the lab: insertion section.Air/water channel.Instrument/suction channel.Auxiliary water channel.Results: test area 1: gram negative bacteria: no growth.Blood agar: growth -microorganism identified: bacillius idriensis.Test area 2: gram negative bacteria: no growth.Blood agar: no growth.Test area 3: gram negative bacteria: no growth.Blood agar: no growth.Test area 4: gram negative bacteria: no growth.Blood agar: no growth.Environmental monitor: tryptic soy agar-no growth.This facility is scheduled to have a site visit from an olympus endoscopic support specialist 23aug2021.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This report is related to the importer's report number: 2951238 - 2021 - 00374.
 
Event Description
It is reported by the customer, two days after a colonoscopy procedure using an evis exera iii colonovideoscope, the patient was diagnosed (using stool studies) with salmonella.The patient required hospitalization and iv antibiotics to treat the salmonella infection.The patient's current condition is described as "discharged".No additional consequences to the patient have been reported.There is no report of device malfunction.The customer further states that another potential source of the salmonella infection is a restaurant.
 
Manufacturer Narrative
This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ifu warns on inappropriate reprocessing as follows: reprocessing manual:1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.Ifu instructs in ¿3.3 inspection of the endoscope¿ to conduct inspection prior to use.Therefore, damage of a-rubber glue in investigation result 1-4 is detectable.3 inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Ifu instructs in ¿3.8 inspection of the endoscopic system/ inspection of the instrument channel¿ to confirm smooth forceps passage at inspection prior to use.Therefore, forceps passage ng in investigation result 1-4 is detectable.Conclusion: the definitive cause of the reported events could not be established.Based on investigation findings the following are possible contributing factors: salmonella was not detected from culture test on the subject scope (although a different microorganism was found).The user mentioned a restaurant as another potential source of salmonella, other than the scope.Damage of the biopsy channel and adhesive rubber was confirmed with physical evaluation of the device.No culture of these specific areas were taken (the sample was taken 20cm from the distal tip), so it it not possible to definitively determine if the damage noted on the device contributed to retention of microorganisms.
 
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Brand Name
EVIS EXERA III COLONOVIDEOSCOPE
Type of Device
COLONOVIDEOSCOPE
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 Key12288277
MDR Text Key265419993
Report Number8010047-2021-09912
Device Sequence Number1
Product Code FDF
UDI-Device Identifier04953170305115
UDI-Public04953170305115
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCF-HQ190L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Other;
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