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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-P6
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 07/31/2020
Event Type  malfunction  
Manufacturer Narrative
During evaluation, olympus found the device had the following malfunctions due to physical stress: deformation or breakage of the control body; bending manipulation and insertion section defects; the connecting parts of the bending tube were coming off (loosening/coming off of screws/peeling off of the glue); and loosened or detached parts joint area on the distal end. Additionally, the device was found to have image problems (black dots) and the control section was broken. The device will be repaired and return to the customer. The operation manual includes cautions regarding the safe and appropriate handling of the device: "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, or control section. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, or light guide cable 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. Do not attempt to bend or twist the endoscope¿s insertion section with excessive force. The insertion section may be damaged. Do not apply shock to the distal end of the insertion section, in particular the objective lens surface at the distal end. Visual irregularities may result. Do not twist or bend the bending section with your hands. Equipment damage may result. " this mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
 
Event Description
The device was returned to the olympus repair center. During evaluation, the repair center identified parts falling off the distal end. There was no patient involvement; the issue was identified during service.
 
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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 Key11007710
MDR Text Key221553000
Report Number8010047-2020-10332
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2018
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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