MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

Model Number UNKNOWN

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Exact pro code unknown-the articles mentions a total of 68 scopes (including 23 gastroscopes (4 therapeutic), 33 colonoscopes (17 pediatric), 7 duodenoscopes and 5 linear echoendoscopes) from one of 2 manufacturers (olympus/pentax) d4: device information: device information is unknown: see above 510k number unknown-see above.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled "scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope", scopes failed adenosine triphosphate (atp) testing and had channel damage when inspected.This study was conducted in the endoscopy unit of a tertiary care academic medical center where >50 endoscopic procedures are performed daily.No human subjects were involved and patient-specific data were not collected.The working channels of all endoscopes in use at our institution manufactured by both olympus¿ (olympus america, center valley, pa) and pentax (pentax of america, montvale, nj) were evaluated at variable intervals between 6 and 72 hours after high level disinfection (hld).Lifetime use history (a surrogate for endoscope age), reprocessing history and date of most recent reprocessing were collated for each endoscope.Endoscope reprocessing: manual cleaning and hld of endoscopes was performed by our institution¿s centralized sterile processing department (spd) in strict accordance with endoscope manufacturer¿s guidelines.Hld was undertaken using an automated endoscope reprocessor (medivatorsadvantage plus, minntech, minneapolis, minn, usa) using the automated cleaning cycle with peracetic acid as the liquid chemical sterilant culminating in alcohol flushing followed by forced air drying for 10 minutes.Endoscopic evaluation of working channels¿after hld, endoscopes were evaluated with an ultra-slim flexible inspection endoscope (stericam, sanovas inc, san rafael, calif).This moisture-resistant flexible inspection endoscope is 110 cm long, with an outer diameter of 2.3 mm, has a light source at its distal tip with adjustable brightness, and a lens that enables high resolution (800 × 800 pixels) video video is viewed on a windows-based computer or tablet equipped with steriviewt device software (sanovas inc, san rafael, calif), which allows capture of both video and still images.Endoscope working channels were examined by manually advancing the stericam both in an anterograde fashion from the endoscope handle, and in a retrograde fashion, from the distal tip of the endoscope, to allow visualization of the entire length of the working channel.The stericam endoscope was reprocessed immediately before each use, as recommended by the manufacturer, with disinfectant wipes (pdi super sani cloth germicidal wipes) for a full 2 minutes of contact time, followed by air-drying for 10 minutes.A total of 85 inspections were performed on all 68 endoscopes in use at our endoscopy unit, including 23 gastroscopes (4 therapeutic), 33 colonoscopes (17 pediatric), 7 duodenoscopes and 5 linear echoendoscopes.Endoscopes were inspected a median of 2 days after reprocessing.Median lifetime use history for all endoscopes was 676 (range 6 to 1919), and 45.6% of endoscopes had >1000 lifetime uses.Median lifetime uses varied by endoscope as follows: gastroscopes 1043 (interquartile range (iqr): 131-1149), colonoscopes 714 (iqr:358-1340), echoendoscopes 660 (iqr: 165-692) and duodenoscopes 244 (iqr:175-249).Since there were no human subjects in this study, and no specific data was provided regarding which scopes had physical damage, one report is being submitted to report the possibility that an olympus scope could have had physical damage that could potentially lead to an adverse event in a patient.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.The definitive cause of the reported events could not be established.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11761555
• MDR Text Key: 270802635
• Report Number: 8010047-2021-05759
• Device Sequence Number: 1
• Product Code: FET
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1