MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 12/14FR X 24 CM 5/BX; ACCESSORIES, CATHETER, G-U

Model Number 61224BX

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

Patient Problems Fever (1858); Pain (1994); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/06/2022

Event Type  Injury  

Event Description

It is reported in the literature titled ¿the lumbosacral angle is a significant predictor for using a semi-rigid ureteroscopic approach in middle ureteral stones,¿ patients experienced adverse effects during and other semi-rigid ureteroscopic procedures.Background: ureteroscopy for middle ureteral stones is often difficult from an anatomical view.This study aimed to evaluate the pelvic anatomy in three dimensions and investigate the relationship between the pelvic anatomy and potential semi-rigid ureteroscopic approach for treating middle ureteral stones.Methods: from a total of 967 patients who underwent ureteroscopy from december 2017 to january 2021, 124 patients who had middle ureteral stones were included in this retrospective cohort study.The pelvic transverse diameter, pelvic vertical diameter, pelvic depth, and lumbosacral angle were measured through preoperative non-contrast computed tomography to define the shape of the pelvic cavity.The relationship between the reachability of the middle ureteral stone using a semi-rigid ureteroscope and the aforementioned anatomical factors, as well as treatment outcomes, was examined retrospectively.Results: the lumbosacral angle and female sex were significant predictors of the possibility of a semi-rigid ureteroscopic approach to middle ureteral stones [odds ratio =1.08; 95% confidence interval (ci): 1.03¿1.14; p=0.003, and odds ratio =3.23; 95% ci: 1.12¿9.32; p=0.03, respectively].The cutoff value of the lumbosacral angle was 149.9°, with a sensitivity of 55.1% and a specificity of 72.7%.The time to reach the stone was longer in the lumbosacral angle <150 degrees group than in the lumbosacral angle > 150 degrees group (p=0.049).Conclusions: in this study, gradual lumbosacral angle and female sex are positive predictors of the reachability of the middle ureteral stone with a semi-rigid ureteroscope.Of all the patients, 6.5% developed ureteral trauma after the procedure (0% in group 1 and 7.1% in group 2).In these cases, double-j stenting was performed, and no stricture occurred later (clavien-dindo classification iii).36.4% of all patients developed renal colic (clavien-dindo classification i: 29.0% in group 1 and 38.5% in group 2).It happened by the following day in most cases.Moreover, the use of uas or double-j stent did not affect the occurrence of colic (p=1.00 and p=0.567, respectively).No ureteral avulsion or perforation was observed in this study.There is no report of olympus device malfunction in any procedure described in this literature.Case with patient identifier (b)(6) reports the uretero-reno fiberscope used in the procedures.Case with patient identifier (b)(6) reports the sheath used in the procedures.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 event 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.

• Brand Name: UROPASS AS 12/14FR X 24 CM 5/BX
• Type of Device: ACCESSORIES, CATHETER, G-U
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15311951
• MDR Text Key: 298805752
• Report Number: 3003790304-2022-00178
• Device Sequence Number: 1
• Product Code: KNY
• UDI-Device Identifier: 00821925035393
• UDI-Public: 00821925035393
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61224BX
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other