MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "CYF-5", EUROPEAN VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The device evaluation has not been completed.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus was informed of a report that the instrument channel came loose and the instrument channel valve came loose.The problem, as reported to olympus, was found on reprocessing.There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was returned to an olympus service center for evaluation.The customer's complaint was confirmed.The device was repaired and returned to the customer.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the event was likely caused by excessive force or rotation stress applied due to user mishandling.This issue is addressed in the instructions for use (ifu) and can prevent occurrence: " important information ¿ please read before use: prohibition of improper repair and modification: do not disassemble, modify or attempt to repair; patient or user injury and/or equipment damage can result.Preparation and inspection of the accessories: inspection of the forceps/irrigation plug: inspect the assembled forceps/irrigation plug for deformation or cracks as described in the forceps/irrigation plug¿s instruction manual.".

• Brand Name: FIBERSCOPE "CYF-5", EUROPEAN VERSION
• 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: 10667334
• MDR Text Key: 214814859
• Report Number: 8010047-2020-07576
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1