MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number OLYMPUS URF TYPE V

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

Patient Problems Fever (1858); Tachycardia (2095); Increased Respiratory Rate (2486); Unspecified Blood or Lymphatic problem (4434)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.

Event Description

On june 21, omsc received the literature "risk factors of infectious complications after retrograde intrarenal surgery: a retrospective clinical analysis".The purpose of the literature was to explore additional risk factors for infectious complications after retrograde intrarenal surgery (rirs).The procedure was performed using flexible ureteroscope (olympus), semi-rigid 8/9.8-fr ureteroscope (non-olympus) and uretral access sheath (non-olympus).This study retrospectively analyzed 602 patients who underwent rirs between december 2016 and october 2019 at the first affiliated hospital of fujian medical university.In the literature, it was reported that infectious complications after rirs (10.58%) and 43 systemic inflammatory response syndromes (sirs) occurred.It was reported, "patients were diagnosed with sirs if they exhibited at least two of the following four criteria:9 (1) body temperature >38 degrees or <36 degrees; (2) respiratory rate >20 breaths/minute or partial pressure of carbon dioxide <32mmhg (<4.3 kpa), at least 12 hours after surgery; (3) heart rate >90 beats/ minute, at least 12 hours after surgery; (4) leukocyte count >12,000 cells/mm3 or <4,000 cells/mm3.Patients who did not meet these criteria were included in the non-sirs group.It was not found whether ¿43 sirs¿ included in ¿infectious complications after rirs (10.58%)¿ or not." it was not also found what severe was and the treatment was required.The literature wrote, ¿in the present study, we found that the rate of infectious complications was lower than that of the study by orsan demir et al.We presume that this difference was observed because patients who underwent rigid ureteroscopy were also included in the croes study, which might have reduced the rate of infection.Furthermore, our findings showed a lower incidence of infection than in the study by baboudjian et al., which involved flexible ureteroscopy.¿ based on the available information, a direct relationship between the olympus product and these complications might not be determined.However, the infectious complications and sirs might be associated with using olympus flexible ureteroscope and might be severe.This is the report regarding the infectious complications and sirs.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12140455
• MDR Text Key: 266258715
• Report Number: 8010047-2021-08619
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2021

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: No Information
• Device Model Number: OLYMPUS URF TYPE V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/08/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other