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

Model Number CYF-5

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the service for evaluation.The cause of the reported event cannot be determined.The instruction manual states, ¿after using the instrument, reprocess and store it according to the instructions in chapters 5, through chapter 9.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.¿.

Event Description

The service center was informed that during set up the scope was inspected and the distal end rubber was noted to be ripped exposing metal.No other damage or abnormalities observed.The scope was removed from the or and sent down to sterile processing.A second scope was brought to the or and the scheduled cystoscopy with a bladder tumor was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results, correct the lot number and device manufacture date.The device was returned to the service center for evaluation.A visual inspection was performed on the returned device and found a bite on the bending section.The bending section rubber and bending section glue were found peeling/damaged on the insertion tube and bending section cover.The image was checked and found multiple fibers broken.The customer¿s complaint of rubber torn/protruding with metal exposed was confirmed.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reports that the root cause could not be identified.The following possible causes for the reported event are presumed as follows: ·since there is damage (a tear, protrusion) observed on the bending tube and the a-rubber, it is presumed that the device was damaged because external force was applied to the distal end.·however, the root cause could not be identified because the subject device was not returned and also there were no photos of a malfunction state and an inspection report attached." the legal manufacturer reports the ifu provides statements to prevent scope damage and recommends the user refer to the following sections: important information ¿ please read before use.Warnings and cautions: follow the warnings and cautions given below when handling this instrument.This information is to be supplemented by the warnings and cautions given in each chapter.Never perform angulation control, suction control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image.Patient injury, bleeding and/or perforation can result.Never insert or withdraw the endoscope¿s insertion tube while the up/down angulation is locked.Patient injury and/or equipment damage can result.Although the illumination light emitted from the endoscope¿s distal end is required for endoscopic observation and treatment, it may also alter living tissues by, for example, causing protein denaturation of liver tissue, or perforation of the intestines.Observe the following warnings with regard to illumination.Always set the minimum required brightness.Keep in mind that the brightness of the image on a video monitor may differ from the actual brightness at the distal end of the endoscope.Pay close attention to the brightness level setting of the light source, particularly when operating the electrical shutter function of a video system.When using a light source and video system that are compatible with the light source¿s automatic brightness control function, make sure to use the function.The automatic brightness control function can better maintain the illumination light level.Refer to the instruction manual of the light source and the video system for further details.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10206656
• MDR Text Key: 224635502
• Report Number: 8010047-2020-03722
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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: 07/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2010
• 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