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

Model Number URF-V2

Device Problems Hole In Material (1293); Material Deformation (2976)

Patient Problem Blood Loss (2597)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus france and was investigated.Olympus france confirmed that a cable support deformed and protruded bending rubber.The subject device was serviced to exchange the insertion unit in september, 2016 and the subject device was used 8 exams.Olympus france supported the user facility for more information and informed that the bleeding occurred in the renal cavities, but the patient needed no treatment for the bleeding and the lesions of renal pelvis.The patient was recovered and good condition.The manufacturing record of the subject device was reviewed with no irregularity relating to the phenomenon.The exact cause of the reported event could not be conclusively determined at this time.If additional and significant information become available, this report will be supplemented.

Event Description

Olympus was informed that during an unspecified procedure, the user facility found a low level of irrigation.When the user facility removed the scope from the patient, the user facility found a hole on the bending rubber and deformation of the bending tube.There was abnormal bleeding of the patient at the end of the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide device evaluation results and additional information.The device referenced in this report was returned to olympus medical systems corp.(omsc) for evaluation.A cable support is a part that is bonded to the bending tube in the bending section.However, based upon the evaluation, it was found that a cable support was peeled off and deformed, and protruded from the bending rubber.There was a hole in bending rubber where the peeled-off cable support was.The exact cause of the peeling-off and deformation of the cable support could not be determined.It is likely caused by an excessive force applied to the cable support because the bending section was angulated to reverse direction while the bending section had been angulated and the movement of the bending section had been limited by the wall of the organ.The exact cause of protruding from bending rubber of the cable support could not be determined.It is considered as one of possible cause that the cable support was interfered with an access sheath.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 6111885
• MDR Text Key: 60288546
• Report Number: 8010047-2016-10060
• 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: Nurse
• Remedial Action: Notification
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• 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
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR