MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The clinical article reported that the ureteroscopes that tested positive were returned to olympus for evaluation; however, since no serial numbers were provided, olympus was unable to perform a device history search and provide details of the evaluation.The article did provide evaluation results for the ureteroscopes.One of the ureteroscope (urf-p6) was found with inadequate image, failed leak test, kinks on the insertion tube, and broken fibers.The 2nd ureteroscope was found with inadequate imaging.The exact cause of the reported event could not be conclusively determined; however, improper maintenance and handling of the ureteroscopes cannot be ruled out as a contributory factor to the reported events.Olympus will continue to investigate this report and if additional information becomes available at a later time these reports will be updated.

Event Description

Olympus received a clinical article on june 14, 2017 titled, ¿the effectiveness of sterilization for flexible ureteroscopes: a real world study.¿ this study involved a total of 16 sterilized ureteroscopes from two unspecified institutions where reprocessing practices were assessed.Microbial cultures, biochemical tests and visual inspections were conducted on these sterilized ureteroscopes.The scopes were examined after manual cleaning and sterilization using hydrogen peroxide gas.Every ureteroscope had visible irregularities, such as discoloration, residual fluid, foamy white residue, scratches, or debris in channels.Tests detected contamination on 100% of ureteroscopes (microbial growth 13%, adenosine triphosphate 44%, hemoglobin 63%, and protein 100%).Microbial cultures were positive from 2 of 16 ureteroscopes (urf-p6 = micrococcus and urf-p6r = corynbacterium glaucum).According to sterile processing department (spd) managers at both sites, institutional reprocessing protocols included immediate bedside precleaning; transportation to spd; leak testing; manual cleaning with enzymatic detergent followed by rinsing; drying with air purges, alcohol flushes, and forced air; sterilization with hydrogen peroxide gas.The reprocessing protocols described by spd managers are consistent with recommendations described in reprocessing guidelines.During both site visits, no bedside precleaning was done by operating room personnel, who acknowledged that they did not customarily perform this step before sending ureteroscopes to the spd for reprocessing.Spd and operating room employees reported occasional delays between procedure completion and the initiation of manual cleaning, and there was no protocol for reporting delayed reprocessing so that it could be addressed in accordance with ifus.In conclusion, the article reports that reprocessing methods were insufficient and may have introduced contamination.The clinical implications of residual contamination and viable microbes found on sterilized ureteroscopes are unknown.Additional research is needed to evaluate the prevalence of suboptimal ureteroscope reprocessing, identify sources of contamination, and determine clinical implications of urinary tract exposure to reprocessing chemicals, organic residue, and bioburden.These findings reinforce the need for frequent audits of reprocessing practices and the routine use of cleaning verification tests and visual inspection as recommended in reprocessing guidelines.Based on the information from the article, olympus is submitting 2 initial mdrs to account for the two ureteroscopes with growth.This is 1 of 2 reports.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6695313
• MDR Text Key: 80027807
• Report Number: 2951238-2017-00435
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Device Catalogue Number: URF-P6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2017
• 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: Initial
• Patient Sequence Number: 1