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

Model Number URF-P5

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The user facility reported that the cover on the fiberscope "urf-p5", set e was peeled off.No patient injury reported.The device was returned to olympus for evaluation.During the evaluation it was found that the insertion tube coating was peeling off.This mdr is being submitted to capture the reportable malfunction that was noted during the evaluation.

Manufacturer Narrative

In addition to the evaluation findings mentioned in the event description the following observations were noted: the angulation in the upward direction is out of standard due to a worn angle wire, liquid leaks due to crumpled part of connecting tube, stain in the screen due to a damaged image guide bundle, discoloration on the light guide lens, and corrosion at the control part due to leakage.A review of the complaint database showed no similar complaint was found with the same model and from the same user facility.According to the dhr review, the subject device was shipped in accordance with the specifications.User can detect the suggested event properly by handling the device in accordance with the instructions for use.Preparation and inspection_ inspection of the endoscope inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.·important information- please read before use warning: do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector 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.·reprocesing: general policy precautions warning: this instrument is not durable or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions.For information on the durability against each method, please contact olympus.If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use and use under responsibility of a physician.Do not use if any abnormality is found.·storage and disposal caution: 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.Based on the dmr investigation result review, the case was not due to design.The legal manufacturer cannot conclusively specify the root cause of the reported event.However, based on the following information, the manufacturer presumed the causes of the suggested event as physical stress, storage environment, and chemical damage.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: FIBERSCOPE "URF-P5", SET E
• Type of Device: 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: 14443374
• MDR Text Key: 294880355
• Report Number: 8010047-2022-08498
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340307
• UDI-Public: 04953170340307
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

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
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2008
• 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