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

Model Number URF-V2

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

Patient Problems Pain (1994); Sepsis (2067)

Event Date 04/10/2023

Event Type  Injury  

Manufacturer Narrative

This device has not been returned for evaluation.Literature article is attached for reference.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "impact of preoperative ureteral stenting in retrograde intrarenal surgery for urolithiasis".Literature summary: background and objectives: ureteral stent insertion passively dilates the ureter.Therefore, it is sometimes used preoperatively before flexible ureterorenoscopy to make the ureter more accessible and facilitate urolithiasis passage, especially when ureteroscopic access has failed or when the ureter is expected to be tight.However, it may cause stent-related discomfort and complications.This study aimed to assess the effect of ureteral stenting prior to retrograde intrarenal surgery (rirs).Materials and methods: data from patients who underwent unilateral rirs for renal stone with the use of a ureteral access sheath from january 2016 to may 2019 were retrospectively analyzed.Patient characteristics, including age, sex, bmi, presence of hydronephrosis, and treated side, were recorded.Stone characteristics in terms of maximal stone length, modified seoul national university renal stone complexity score, and stone composition were evaluated.Surgical outcomes, including operative time, complication rate, and stone-free rate, were compared between two groups divided by whether preoperative stenting was performed.Results: of the 260 patients enrolled in this study, 106 patients had no preoperative stenting (stentless group), and 154 patients had stenting (stenting group).Patient characteristics except for the presence of hydronephrosis and stone composition were not statistically different between the two groups.In surgical outcomes, the stone-free rate was not statistically different between the two groups; however, the operation time for the stenting group was longer than that of the stentless group.There were no differences in the complication rate between the two groups.In the complication category, two patients in each group experienced postoperative sepsis requiring inotropes, which improved with continued iv antibiotics.Two patients in the stenting group required postoperative blood transfusion.One clavien¿dindo grade 3a patient who had a postoperative cystoscopic ureteral stent exchange under local anesthesia due to severe pain was in the stentless group.Conclusions: among surgical outcomes for rirs with a ureteral access sheath, preoperative ureteral stenting does not provide a significant advantage over non-stenting with respect to the stone-free rate and complication rate.Type of adverse events/number of patients: cd grade2, and 3a complication (7).

Manufacturer Narrative

Updated: b5.

Event Description

Olympus further received information from the author that there was no product malfunction and no adverse events caused by olympus device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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

Other related patient identifiers: (b)(6).

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• 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: 16922698
• MDR Text Key: 315193901
• Report Number: 9610595-2023-07425
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

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-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 05/18/2023; 06/22/2023
• Supplement Dates FDA Received: 06/13/2023; 07/17/2023
• 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
• Treatment: 61124BX UNKNOWN LOT
• Patient Outcome(s): Required Intervention