MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN

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 has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc could not review the service and manufacturing history (dhr) because the serial number was not described on the literatures.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

On april 2nd, 2019, olympus medical systems corp.(omsc) received a literature titled ¿percutaneous nephrolithotomy in transplant patients¿.The literature reported that 2,753 procedures of percutaneous nephrolithotomies were conducted between january 1980 and january 2017.However, the scope used for those procedures were not described on the literatures.Therefore, olympus followed up with the author of this literature, and on may 20th, 2019, olympus was informed that the author possessed the olympus ureterorenoscope (urf-p5 and urf-v) and the non-olympus ureterorenoscope in that period.The literatures reported that one case of renal bleeding which required embolization occurred.There was no information on which model of the endoscope was used in each procedure.Further detailed information such as the relationship between the olympus ureteroscope (urf-5 and urf-v) and the reported complication could not been obtained at present.Therefore, according to the number of the complication known, omsc is submitting one medical device report.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 8702874
• MDR Text Key: 148155565
• Report Number: 8010047-2019-02200
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/17/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other