MAUDE Adverse Event Report: GYRUS ACMI, INC UROPASS AS 10/12FR X 24 CM 5/BX; SHEATH

Model Number 61024BX

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

Patient Problems Myocardial Infarction (1969); Urinary Tract Infection (2120); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Date 12/17/2021

Event Type  Injury  

Event Description

Olympus reviewed a literature titled "prognostic factors for the safety and efficacy of retrograde laser lithotripsy: data from a contemporary series of 155 consecutive patients with single and multiple lithiasis of the urinary tract".This prospective study was aimed to evaluate the results and complications of retrograde endoscopic lithotripsy for stones located in the urinary tract and to determine prognostic factors for treatment outcome.The prognostic factors for the stone-free rate (sfr) after the 1st and subsequent sessions and overall complications were assessed.Patients were divided into single or multiple lithiasis groups (groups a and b respectively).A comparison between these two groups was then conducted.Overall, 237 stones were detected in 155 patients, representing a mean burden of 1.53 stones per patient.The mean total stone size was 14.7 mm, the initial sfr was 80% and the final sfr (after a mean of 1.23 sessions per patient) was 94.2%.The rate of complications was 26.4%.Multivariate analysis revealed that preoperative stenting and total stone size were independent prognostic factors of initial sfr, while no independent factors were determined for final sfr.Age, total size, and stones in the lower calyx were independent factors for complications.In groups a and b, 114 and 41 cases with solitary and multiple stones were included, respectively.Excluding operation time (p=0.002), no significant differences were recorded in terms of initial (p=0.255) and final sfr (p=0.056), hospital stay (p=0.308), the mean number of treatments (p=0.757), and the rate of complications (p=0.218) between the two groups.In conclusion, retrograde endoscopic management of multiple lithiasis has a favorable outcome irrespective of stone location.Older patients with higher burdens and stones in the lower calyx should be treated with caution.The authors used the following three olympus devices: (b)(6): nt4w30115: larger stone fragments were removed with either a 1.8 or a 3f nitinol tipless basket ((b)(4)).(b)(6): urf-p6,uretero-reno fiberscope: stones proximal ureter and all the renal ones were fragmentized with a 4.9/7.95 f flexible ureteroscope (urfp6, olympus).(b)(6): 61024bx, uropass as 10/12fr x 24 cm 5/bx: 10-12f access sheaths (uropass, gyrus medical ltd.) were used to facilitate the reinsertion of the flexible scope.Type of adverse events/number of patients: urinary tract symptoms (number of events not reported).Fever ((number of events not reported).Hematuria (number of events not reported).Uti (number of events not reported).Sepsis (11).Ureteral trauma (number of events not reported).Ureteral stenosis (number of events not reported).Acute myocardial infarction(1).This report is 3 of 3 for: (b)(6): 61024bx, uropass as 10/12fr x 24 cm 5/bx: 10/12f access sheaths.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 10/12FR X 24 CM 5/BX
• Type of Device: SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave n; brooklyn park MN 55445
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14166831
• MDR Text Key: 289745590
• Report Number: 3003790304-2022-00055
• Device Sequence Number: 1
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 61024BX
• 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: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN LOT/SERIAL: NT4W30115, URF-P6
• Patient Outcome(s): Other