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

Model Number URF-P5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) has been made aware of a literature titled ¿comparison of perioperative outcomes of nurse-assisted or one person f-tul conducted by a single physician¿ that was presented at the 32nd congress of japanese society of endourology.The literature reports the result of 52 cases of transurethral ureterolithotripsy (tul) conducted between may 2017 and april 2018 at a user facility, using olympus uretero-reno fiberscope model urf-p5.In the literature, it is reported as adverse events that postoperative febrile urinary tract infections (uti) (nine cases) and a ureteral injury (one case) occurred as a result of the procedures.Moreover, the patient who suffered from a ureteral injury was required to have a stent placement for two months as well as subsequent extracorporeal shock wave lithotripsy (eswl) due to the injury.According to the literature, the perioperative outcomes of the both groups (nurse-assisted or one person f-tul) were equivalent.However, uti frequently occurred in the both groups are compared to reports written by experts.Thus, it is concluded that there is still room for further improvement of tul conducted by the subject physician.Any further detailed information have not been obtained to date.Omsc is submitting mdr according to the number of types of the adverse events.This is two of two reports related to ureteral injury.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8201845
• MDR Text Key: 131592991
• Report Number: 8010047-2018-02593
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: URF-P5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other