MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that five patients developed cystitis after procedures using this product.The device had been reprocessed by an non-olympus automated reprocessing machine espal.According to the user facility, the manufacturer has confirmed the reprocessing machine has no problem.Therefore, the user facility suspects that the olympus endoscope caused the patient infections and contacted olympus to ask for investigation.A total of five reports are being submitted for the five patients.This is the 5th of 5 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The evaluation of the subject device by olympus medical systems corp.(omsc) confirmed following: the device passed the leakage testing.Some residues remained on the light guide lens, the objective lens and the distal end of the instrument channel.The residue on the distal end of the instrument channel could be easily scrubbed off.It is considered that the remained residues caused due to insufficient reprocessing.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, it is unlikely that the reported event occurred due to the scope, because there was no damage that may result in insufficient reprocessing.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10716977
• MDR Text Key: 213483976
• Report Number: 8010047-2020-07994
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

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: CYF-5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other