MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P6

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information has been requested but no information was received at this time.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "o-37-2 initial experience with mini-ecils with negative pressure suction access sheath (clearpetra)." objective: percutaneous nephrolithotripsy (pnl) for renal ureteral stones is the most invasive of urinary tract stone surgery, and complications such as bleeding and postoperative infection are problematic.It has been suggested that the use of a negative pressure suction access sheath (clearpetrar16fr) as a tract may reduce the risk of developing postoperative utis.In our department, we introduced mini-ecils using clearpetra, so we retrospectively examined its initial experience.Methods: for nephroureterolithiasis, we have experienced mini-pnl using clearpetra as a tract in 37 cases since april 2020.Of these, ecils was performed in 12 cases.Results: the median age was 62 years, the bmi was 25.3, and the pre-existing dm or cardiovascular disease was observed in 3 patients (25%).Six patients (50%) had preoperative pyelonephritis, and all of them had preoperative drainage.The mean preoperative stone diameter was 17.7 mm and the area was 284 mm2.The average endoscope usage time was 78 min, and the sfr was 75.0%.Two cases of renal haemorrhage were observed as postoperative complications, and additional treatment was required in two cases (18%).The average length of hospital stay was 12 days.Type of adverse events/number of patients renal haemorrhage (2) there is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received from the author (updated field b5).The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

Event Description

No olympus device cause or contribute to any of the patient adverse events described in this literature.No olympus device malfunction during any procedure described in this literature.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18369420
• MDR Text Key: 331048566
• Report Number: 9610595-2023-20028
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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-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: Not provided
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 01/11/2024
• 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): Required Intervention