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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 Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Uterine Perforation (2121)
Event Type  Injury  
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 information was obtained. The device was not returned to olympus for evaluation. The exact cause for the reported event cannot be determined. However, based on similar reported events the most likely cause of the broken skeleton could be attributed to the operator¿s technique. 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
The user facility informed olympus that during an unspecified procedure, the laser fiber from the scope¿s broken bending section detached and punctured the patient¿s uterus. It is unknown if the patient required treatment or if the intended procedure was completed.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation findings. The device was returned to olympus for evaluation. The evaluation found the bending section skeleton broken with the metal tab exposed through the bending section cover near the insertion tube side of the scope. Upon removing the bending section cover, evidence of corrosion was noted on the bending section skeleton. The device was serviced and returned to the user facility.
 
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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
MDR Report Key7341645
MDR Text Key102497156
Report Number2951238-2018-00181
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Device Catalogue NumberURF-V2R
Device Lot NumberN/A
Other Device ID Number04953170343612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1251-2017

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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