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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 Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the manufacturer for evaluation and the customer¿s complaint was confirmed. The a-rubber was found to have multiple leaks. On removal of the bending section cover (a-rubber) from the bending section, the service technician noted multiple bending support pins were detached, which produced sharp edges that ruptured the a-rubber. This type of physical damage is attributed to mishandling. A review of the device history record found no issues that could have caused or contributed to the reported issues. The ifu includes the following information regarding 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. ¿ in addition, the ifu warns, ¿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. ¿ 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 user facility reported to olympus that the device was leaking from the distal end. The issue was observed during reprocessing of the device. There was no patient involvement.
 
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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 Key10992946
MDR Text Key220982264
Report Number8010047-2020-10242
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340833
UDI-Public04953170340833
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2020
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 Manufacturer08/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2018
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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