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

Model Number URF-P7

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/25/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "living donor-gifted allograft lithiasis: surgical experience after bench surgery stone removal and follow-up." literature summary: this retrospective study presents the surgical experience and long-term outcomes of living donor kidney transplantations involving asymptomatic kidney stones, using ex vivo flexible ureterorenoscopy (f-urs) during bench surgery for stone removal.A total of six living kidney transplants were analyzed.The median (iqr) size was 6 (4¿13) mm.The median (iqr) stone density was 715 (189¿1700) hu.Four lithiasis (67%) were in the lower calyx.Kidney stone analysis was performed in all cases, most of the calculi contained whewellite as the main component (66.7%).Median cold ischemia time was 41.6 (37¿46) minutes with complete stone removal in all cases.During follow-up, six years later, the patient still presented good kidney function, with 1.63 mg/dl creatinine levels and a stone-free status.After a median (iqr) follow-up of 120 (2.75¿359.2) none of the recipients or living donors presented urinary stone recurrence.The findings suggest that bench f-urs is a safe approach for managing urinary stones in kidney grafts, providing good functional outcomes without stone recurrence in selected cases.Median cold ischemia time was 41.6 (37¿46) minutes with complete stone removal in all cases.Neither nonimmediate bleeding nor acute rejection was observed (table 2).As immediate postoperative complications, one patient developed paralytic ileus managed with mobilization and prokinetics.Another patient developed delayed graft function, being the two-stage case, with the longest cold ischemia time of the series.During follow-up, six years later, the patient still presented good kidney function, with 1.63 mg/dl creatinine levels and a stone-free status.Another patient presented good postoperative evolution, but seven days later presented signs of arterial thrombosis, confirmed by echo-doppler, therefore, a transplantectomy was performed.Type of adverse events/number of patients: event1: paralytic ileus - 1 patient (recipient#1/ 63 years old/ male).Event2: arterial thrombosis - 1 patient (recipient#2/ 45 years old/ male).Event3: wall hematoma - 1 patient (recipient#4/ 34 years old/ female).This literature article requires 6 reports.The related patient identifiers are as follows: (b)(6): for urf-p7/event1 (recipient#1).(b)(6): for 5920002bx/event1 (recipient#1).(b)(6): for urf-p7/event2 (recipient#2).(b)(6): for 5920002bx/event2 (recipient#2).(b)(6): for urf-p7/event3 (recipient#4).(b)(6): for 5920002bx/event3 (recipient#4).This medical device report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

The suspect device has not been returned to olympus.The investigation is in process.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the information supplied by the author of the study.

Event Description

The author of the study provided additional information indicating no olympus device malfunctioned during any procedure reported in the study.The adverse events reported are post-surgical complications, but no olympus device caused or contributed to any adverse events reported.

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.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• 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: 17785662
• MDR Text Key: 323895296
• Report Number: 9610595-2023-13717
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2023

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-P7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 10/03/2023
• Supplement Dates FDA Received: 10/02/2023; 10/06/2023
• 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: 5920002BX IRRIGATION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male