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Model Number URF-P6R
Device Problems Break (1069); Device Maintenance Issue (1379); Material Perforation (2205); Improper Device Output (2953); Material Deformation (2976); Material Integrity Problem (2978); Output Problem (3005)
Patient Problems Fever (1858); Hematoma (1884)
Event Date 11/28/2016
Event Type  Injury  
Manufacturer Narrative
According to the service record, the subject device was returned to olympus medical systems (b)(4) on september 13, 2016. Based on the record, ¿down¿ angulation wire was broken at the bending side. The field of view was foggy. There were corrosion inside of the eyepiece unit and the control unit. The venting connector was deformed. There was a burnt mark on the distal tip cover. The instrument channel was deformed at the distal end. The bending rubber had an unspecified breakage. There were scratches on the objective lens. Approx 20 percent of the light guide was broken. Though there were malfunction, the subject device was not repaired at the service and returned to the user facility on october 14, 2016. After this event occurred, the subject device has been returned to (b)(4) for investigation. Based on the investigation, an additional malfunction to the last service was confirmed that there was a water leakage at the instrument channel. The manufacturing record of the subject device was reviewed with no irregularity relating to the phenomenon. The exact cause of the event could not be concluded at this moment. If additional and significant information becomes available, this report will be supplemented.
Event Description
Olympus was informed that the patient got a fever and perinephric hematoma. The patient was undergone a therapeutic procedure with the subject device. On (b)(6) 2016, the patient had an ureterorenoscopy with an unspecified semi-rigid scope and a lithoclast to retrieve stone in the right upper ureter and inferior calyx. On (b)(6) 2016, the subject device was used to diagnose the treated area. On that day, 150 ml blood mixed fluid drained with urine. The patient was released on the day. On the next day, the patient got a fever. On (b)(6) 2016, the patient was hospitalized for the fever and the perinephric hematoma, and then released on (b)(6) 2017.
Manufacturer Narrative
This report is being submitted to provide additional information. The device referenced in this report was returned to olympus for evaluation. According to the evaluation, no peeling of the cable support and no damage to the bending tube were found. Since metal corrosion was observed on the bending tube, it is considered that water intruded into the inner part of the device. There was a cutting found inside the biopsy channel. On the inner surface at 25mm from the end of the biopsy channel, a scratch and the hole that causes leakage were observed. The angulation wire on the down side was broken, and the broken wire adhered to the inner part of the coil pipe in which the angulation wire was inserted. Corrosion was found on the fixing part for the coil pipe and the connecting part on the proximal side of the insertion tube. For the external tube of light guide and image guide near the connecting part on the proximal side of the insertion tube, a trace of water intrusion was observed. The exact cause of the reported event could not be conclusively determined, but it is considered that renal calix may be damaged because the doctor used the subject device in a condition where the bending function could not be functioned, so the scope was operated in an unintended direction.
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Manufacturer (Section D)
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 
MDR Report Key6295694
MDR Text Key66321563
Report Number8010047-2017-00111
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Other Device ID Number04953170340833
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/02/2017 Patient Sequence Number: 1