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

Model Number CYF-5

Device Problem Device Reprocessing Problem (1091)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to any of olympus locations.Therefore, olympus could not investigate the subject device.Omsc could not review the manufacturing history record (dhr) because the serial number was unknown.The exact cause of the reported event could not be conclusively determined.However, based upon the information from olympus (b)(4), there was the possibility that this phenomenon was attributed to the human error.Olympus stated the appropriate reprocessing of cyf-5 and the counter measures against abnormalities in the instruction manual of cyf-5.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during reprocessing, it was found that the following.¿the department provides decontamination and sterilization service to both internal and external customers.The department is accredited to iso 13485:2016.On occasions we process flexible cystoscopes for an external customer north bristol nhs trust.On the (b)(6) is was brought to our attention by our external authorized engineer for decontamination that the department had been processing this particular model of flexible cystoscope on the flex cycle instead of the duo cycle which is advised by the manufacturer in their instructions for use.¿ the facility staff had reviewed, amended/updated and shared the procedure.Also they had reminded of the importance of checking the manufacturers ifu's before processing medical devices.There was no report of patient injury associated with the event.

• 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: 11868107
• MDR Text Key: 252332363
• Report Number: 8010047-2021-06624
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• 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