MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN; URETERO-RENO SCOPE

Model Number UNKNOWN

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 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) received a literature titled ¿clinical study of f-tul for kidney stones in our center¿.The literature reported the result of the tul procedures for kidney stones in 371 cases and the procedures were conducted between january 2007 and december 2017 at the user facility.In the procedures, olympus uretero-reno scope model urf-p5, urf-p6 and urf-v were used and 9 cases of ureteral injury, 1 case of under the kidney capsule hemorrhage, 3 cases of the ureteral stenosis, and 13 cases of pyelonephritis as complication reportedly occurred.Any further detailed information have not been obtained at this time.Omsc is submitting mdr according to the number of types of the adverse events.This is 1 of 4 reports.(related to ureteral injury).

• Brand Name: UNKNOWN
• Type of Device: URETERO-RENO SCOPE
• 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: 8634879
• MDR Text Key: 145930444
• Report Number: 8010047-2019-01992
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other