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

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.

• 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 Key: 12288277
• MDR Text Key: 265419993
• Report Number: 8010047-2021-09912
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 03/04/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other