MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E; URETERO-RENO FIBERSCOPE

Model Number	URF-P5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that it was found that the coating of the insertion tube had been partially peeled off more than 4mm during the incoming inspection for the repair of the subject device at olympus (b)(4).The occurrence date of the event is unknown, and there was no report of patient injury associated with this event.
Additional Manufacturer Narrative
The subject device was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomenon, and also found that this phenomenon was attributed to the deterioration.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the issue occurred due to improper handling and/or reprocessing.A definitive root cause cannot be identified.Handling and reprocessing is covered in the instructions for use: ifu.Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, and control section with excessive force.The endoscope may be damaged and could cause patient injury, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient.·do not press the insertion tube against the sheath grip forcefully.The insertion tube may become damaged.·if necessary, apply a medical grade, water-soluble lubricant to the endoscope¿s insertion tube.·compatible reprocessing methods and chemical agents : detergent solution : use a medical-grade, low-foaming detergent, neutral ph detergent or enzymatic detergent and follow the manufacturer¿s dilution and temperature recommendations.Contact olympus for the names of specific brands that have been tested for compatibility with the endoscope.Do not reuse detergent solutions.·the storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.Storing the endoscope in direct sunlight, at high temperatures, in high humidity or exposed to ozone, x-rays and/or ultraviolet-rays may damage the endoscope or present an infection control risk.Olympus will continue to monitor the field performance of this device.

• Brand Name: FIBERSCOPE "URF-P5", SET E
• Common Device Name: URETERO-RENO FIBERSCOPE
• 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: 12960511
• Report Number: 8010047-2021-15748
• Device Sequence Number: 5424065
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown