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

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.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6295694
• MDR Text Key: 66321563
• Report Number: 8010047-2017-00111
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6R
• Other Device ID Number: 04953170340833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 75