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

Model Number URF-P6

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "comparative study of mini-pnl and ecirs combined with negative pressure suction access sheath (clearpetra)".Literature summary purpose: for kidney ureduct stone disease at our hospital from april 2020, negative pressure suction application system (clearpetra16fr) as a tract mini-pnl has been tested in 37 cases so far.The ecirs was administered in 12 of the cases to compare the ratio b method: there were 25 cases (cp group) in which mini-pnl was administered using clearpetra as a tract.Ecirs was administered using clearpetra as a tract in 12 cases (ce group).Intermediate and perioperative periods, litholitus elimination rate (sfr), and postoperative complications were examined.They used a 12fr hard renal mirror manufactured by storz for both groups.Ecirs used olympus' urf-p6.Result: the median age is 61:62 years in the mp and ce groups, bmi is 23-8: vs25.3, dm and cardiovascular disease were found in 6 (24%) and 3 (25%), respectively.Preoperative renal nephritis: the cases of disease were 4 (16%) in the mp group and 6 (50%) in the ce group, with a large number of ce (p=0.038), and preoperative drainage were also common in the ce group.The straight diameter of the preoperative flat stone is 20.8 mm in the mp group and 20.8 mm in the ce group.At 17.7 mm (p=0.15), the area area is 292 mm2 in the mp group and 284 mm2 (p = 0.46) in the ce group.There was no difference of endoscopic procedure time between 69 min in the mp group and 78 min in the ce group (p
=
o.79), sfr was 81.8% in the ce group compared to 88.5% in the mp group (p=0.62).Postoperative complications: renal hemorrhage was observed in 1 patient in the mp group and 2 patients in the ce group, and additional treatment was observed in 3 patients (11.5%) in the mp group, and in the ce group, it took 2 cases (18%).Both were 12 days on average for each hospital.Conclusion both the mp group and the ce group maintained high sfr and showed no particular difference.Type of adverse events/number of patients: renal hemorrhage (2) 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.Additional information has been requested.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

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: 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: 17886194
• MDR Text Key: 325090046
• Report Number: 9610595-2023-14724
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/01/2023
• 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
• Patient Outcome(s): Other