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

Model Number CYF-5

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, the device ¿a-rubber¿ exploded off the instrument.The issue occurred during sterilization in sterrad sterilization device without sterrad cap.There was no patient harm or impact on this reported event.No user injury was reported.Device evaluation found the bending rubber is broken, rupture and the metal is sticking out.

Manufacturer Narrative

The subject device was received and evaluated at (rrc) regional repair center, olympus prerov.Device evaluation found the bending rubber is broken, rupture and the metal is sticking out.Service repair noted that the failure found was due to customer handling.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Conclusions: we could not identify the root cause of these phenomena.Investigation confirmed the following.A-rubber is damaged, and the metal part is sticking out.Unable to determine if the damage was caused by stress or handling.As a result of the manufacturing record review , the subject device was shipped without any abnormality in manufacturing.Judging from the above and based on the fact that the bending section was damaged, it can be assumed that the metal part sticked out due to the internal blade was damaged due to an external force applied to the bending section.However, we were unable to determine if external force was due to handling or other factor.As stated on the ifu (instruction for use) the user manual states: 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.Olympus will continue to monitor complaints for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12683893
• MDR Text Key: 282045125
• Report Number: 8010047-2021-13554
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 09/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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
• Treatment: STERRAD NX STERILIZER.