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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2R
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The customer reported to olympus the subject device was not working when inspected prior to use before an unknown procedure. The customer returned the subject device to olympus for repair. The olympus repair department identified the distal sheath was rough with wear and tear from the bending part. No further inspection could be performed.
 
Manufacturer Narrative
(b)(4). Event description: evaluation result: a-rubber and bending section are broken ssb2222a. Due to a cut on a-rubber, water tightness is lost: ssl1202c. Lg lens has discoloration: sse2431b. Due to deformation of bending tube, connection between bending section and connecting tube is not secured: ssb2111a. Adhesive on a-rubber has wear: sse2519a. A-rubber has cut: ssb2232. Bending tube is deformed: ssb1215b. Connecting tube has a dent: ssb2315a. Due to wear of angle wire, bending angle in up/down direction does not meet the standard value: ssb1214a. Due to damage on ccd unit, foggy image occurs: ssi3201a. Due to damage on ccd unit, the image has roughness: ssi3001b. Due to damage on ccd unit, the specified resolving power is not obtained: ssi3101b. Precautions: perform a leakage test on the endoscope after each precleaning procedure. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. Use of a leaking endoscope may also pose an infection control risk. Inspection of the endoscope: inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities. Do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved. The bending section may be damaged. Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc. Do not insert the insertion tube with excessive force and twist. Do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged.
 
Manufacturer Narrative
Correction: device manufacture date. Initial reporter occupation ¿ three attempts were performed to obtain occupation for the reporter but were not successful. If additional information is obtained at a later date, a supplemental report will be submitted. 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. It was presumed that the cause was breakage of the bending section due to user manipulation that applied excessive force to the bending section. The user is able to detect the suggested event appropriately by handling the device in accordance with the following instructions for use (ifu): "precautions: perform a leakage test on the endoscope after each precleaning procedure. Do not use the endoscope if a leak is detected. Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions. Use of a leaking endoscope may also pose an infection control risk. Inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities. " the user is able to reduce/prevent occurrence of the suggested event by handling the device in accordance with the following ifu: "do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved. The bending section may be damaged. Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc. Do not insert the insertion tube with excessive force and twist. Do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. " olympus will continue to monitor field performance for this device.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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 Key13195172
MDR Text Key291730508
Report Number8010047-2022-01083
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170343612
UDI-Public04953170343612
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2017
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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