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

Model Number URF-V2

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On july 13, 2020, olympus medical systems corp.(omsc) received literature titled "pre-use ureteroscope contamination after high level disinfection: reprocessing effectiveness and the relation with cumulative ureteroscope use".In the literature, it was reported that the result of the microbiological test using olympus endoscope and non-olympus endoscope from december 2015 to december 2017.And, in the postoperative period, the adverse events of urinary tract infection symptoms were reported in 25 of 389 procedures.It was not reported that a direct relationship between the subject device and the observed adverse events.It was reported that the subject device or other device was used with the procedure.Therefore, it was not identified which device was used for the related procedure.Therefore, omsc will submit a medical device report (mdr) for the type of adverse event of the subject device.In contrast, as a result of the microbiological testing, the following microbes were detected.Urf-v2 (2 scopes) : uropathogens (10 cfu/ml or greater) urf-v2 (7 scopes) : skin flora (30 cfu/ml or greater) urf-p6 (4 scopes) : skin flora (30 cfu/ml or greater) there was no other information about the infection in this literature.Based on the available information, other detailed information such as the number of microbes and serial number was not provided.Therefore, omsc will submit 13 medical device reports (mdr) depending on the number of endoscopes.This report is 4 of 14 reports.(this is a report about the microbiological testing).

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 10354676
• MDR Text Key: 224676329
• Report Number: 8010047-2020-05158
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• 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