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

Model Number URF-V

Device Problems No Display/Image (1183); No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report was returned to olympus medical systems corp.For evaluation.During the evaluation, the reported phenomenon duplicated.There was a pinhole inside the instrument channel and corrosion inside the bending rubber.The pinhole was close to the instrument channel port and the inside wall of the instrument channel was scraped and scratched.The manufacturing record of the subject device was reviewed with no abnormality possibly associated with the reported phenomenon.The exact cause of the reported event could not be conclusively determined, but water or chemical solution may intrude from the pinhole of the instrument channel into the subject device and cause damage to the image unit as there was a pinhole inside the instrument channel and corrosion inside the bending rubber.Possible causes for the scraped and scratched channel are to insert a therapeutic device with scratches or deformation or to insert a forceps while the cup is open.If additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that the video image of the subject device became dark during an unspecified procedure.The procedure was completed with another device.There was no patient injury reported.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6590086
• MDR Text Key: 76043483
• Report Number: 8010047-2017-00642
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physicist
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2017
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1