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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is being submitted to make a correction on the procode.
 
Manufacturer Narrative
As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The scope was returned to olympus for evaluation. The evaluation confirmed the reported device damage and found the bending section broken along the image fiber and biopsy channel of the scope. In addition, the bending section sheath was found torn. The bending section glue was also found cracked and pieces of the glue missing. The scope was serviced and returned to the user facility. Based on the evaluation findings and reported event, it is likely that the unspecified accessory that was used with the device caused a restriction inside the insertion tube of the scope causing the user to use excessive force to insert and remove the accessory from the insertion tube. The original equipment manufacturer (oem) performed investigations related to this device issue. As a result, the oem has conducted a field corrective action including a distribution of ¿instructions for safe use¿ to mitigate the potential risk of patient injury. The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury. ¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient. If the up/down angulation control lever does not move. If the angulation control mechanism is not functioning properly. Visually inspect the bending section for no metallic parts protruding from the bending section. Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight. Visually inspect the bending section for abnormal bending shape, or other irregularities. Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation. ".
 
Event Description
Olympus was informed that during an unspecified procedure, the scope broke in half and wires became exposed. The damage occurred when the physician was attempting to put a wire down the scope. No laser was used. The scope was used 3-4 times prior to this incident. There was no patient injury reported.
 
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Brand NameOES URETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key7064658
MDR Text Key191937215
Report Number2951238-2017-00748
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Device Catalogue NumberURF-P5
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
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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