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 Hematuria (2558)

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 record (dhr) because the serial number was not described on the literatures.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 ¿treatment of renal stones with retrograde intrarenal surgery in a regional hospital¿.The literature reported that seventy procedures of the retrograde intrarenal surgery (rirs) were conducted using a non-olympus ureterorenoscope (richard wolf (b)(4)) or an olympus ureterorenoscope (urf-p5) with the unspecified ureteral access sheath (10/12 fr or 12/14 fr).Renal ultrasound and kidney, ureter and bladder (kub) were conducted in all patients fifteen and thirty days after rirs for hydronephrosis and residual fragments.Rirs in case of the kidney or rigid ureterorenoscopy in the case of the ureter were conducted for residual fragments.The literatures reported that complications occurred as follows; early abortion of the procedure due to gross hematuria: one case.Fever: seven cases.It was reported that all of the reported complications were not serious injury.The literature concluded that rirs is safe and effective treatment.Further detailed information such as the relationship between the subject device and all of the reported complications could not been obtained at present.Therefore, according to the number of the type of complications known and the number of olympus device used for procedure, omsc is submitting two medical device reports.This is a report on early abortion of the procedure due to gross hematuria and one of two reports.

• 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 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: 8547993
• MDR Text Key: 143259871
• Report Number: 8010047-2019-01837
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K912120
• 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: 04/25/2019

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: 04/02/2019
• Initial Date FDA 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other