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

Model Number URF-P6

Device Problems Break (1069); Display Difficult to Read (1181)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The subject devices have not been returned to omsc but were returned to olympus (b)(4) (oekg) for evaluation.In the evaluation of oekg the following was confirmed; leak from the a-rubber bending section bending section broken (no external protrusion) image guide bundle was damaged omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The user admitted that he pushed the device with excessive force and it led to the breakage.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that during the retrograde intrarenal surgery (rirs) using the subject device, the bending section of the subject device was broken and the endoscopic image got abnormal.The user replaced the subject device to another one and completed the procedure.There was no report of patient injury associated with the event.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9761921
• MDR Text Key: 222561064
• Report Number: 8010047-2020-01536
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K172298
• 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
• Report Date: 02/27/2020

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: No Information
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1