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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6R
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/29/2021
Event Type  malfunction  
Event Description
It was reported by the customer, a fiber was broken on the uretero-reno fiberscope and the image was blurry and had multiple black dots. No leakage was found. No patient harm reported. During the evaluation of the device, it was noted the connecting tube had coating peeling. This report is to capture the reportable peeled coating on the connecting tube noted at estimation.
 
Manufacturer Narrative
The device was returned to olympus for evaluation and the reported image issue was not confirmed. The issue of the broken fiber was confirmed. The image guide fiber bundle had significant breakages. Additional issues were found. Due to a dent on distal end, a cut on the bending section cover and cut on the connecting tube, water tightness was lost. The light guide lens had discoloration. The distal end had a burn. The adhesive on the bending section cover was detached. The bending section cover had a scratch. The venting connector under grip was shaved. The angulation lever was deformed. Due to damage on the bending tube, the bending angle in the up/down direction did not meet the standard value. Due to damage on the channel tube, the forceps and the channel cleaning brush could not be inserted smoothly. Due to damage on the connecting tube, the metal part was exposed. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
 
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, a definitive root cause could not be established. The suggested phenomenon was presumed to be due to the following: physical stress such as scratching/ striking the insertion section. Chemical stress by deviating from the ifu (instructions for use) (reprocessing manual) stress by storing devices in poor circumstances such as in direct sunlight, at high temperatures, in high humidity or exposed to x-rays and/or ultraviolet-rays. The ifu (operation manual) warns regarding applying external stress to insertion section as follows: "important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector. Also, do not bend, pull, or twist 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, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. " the ifu (reprocessing manual) warns regarding reprocessing deviated from ifu as follows: "for information on the durability of olympus equipment against a particular reprocessing method, contact olympus. In general, olympus cannot guarantee the effectiveness, safety, and durability of reprocessing methods not described in this reprocessing manual. If you choose to use a reprocessing method not recommended in this manual, the local institution and/or physicians must assume responsibility for its safety and efficacy. Make sure to carefully inspect each piece of endoscopic equipment for irregularities (damage) prior to each patient procedure. Do not use the equipment if any irregularity is found. " the ifu (reprocessing manual) warns on storing devices in poor circumstance as follows: "store the endoscope and accessories in an endoscope storage cabinet that also protects the equipment from physical damage. To prevent damage, do not store the endoscope and/or accessories in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays, ultraviolet rays, or ozone. To prevent damage, do not store the endoscope and/or accessories with chemicals or in a gas-generating area. Do not coil the endoscope¿s insertion tube or universal cord with a diameter of less than 12 cm. Such improper storage may damage the endoscope. " olympus will continue to monitor field performance for this device.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the customer.
 
Event Description
Additional information was received from the customer. The issue was found during preparation for use for a therapeutic retrograde intrarenal surgery (rirs). The intended procedure was completed with another device with no significant delay. The device was inspected prior to use. Multiple black dots were found as well as blurred vision.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-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 Key13333500
MDR Text Key295411763
Report Number8010047-2022-01854
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340833
UDI-Public04953170340833
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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