MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR; KIT, NEPHROSCOPE

Model Number	A37025A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Convulsion/Seizure (4406); Blood Protein Abnormal (4595)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled ¿the effect of endoscopic renal and ureteral stone surgeries on renal blood flow in children: a prospective trial¿.Literature summary aim: to assess the impact of endoscopic stone surgeries on renal perfusion and blood flow in children.Materials and methods: children who underwent percutaneous nephrolithotomy (pcnl), retrograde intrarenal surgery (rirs), ureterorenoscopy (urs), endoscopic combined intrarenal surgery (ecirs) were included to the study.Renal doppler ultrasonography (rdus) was performed one day before the operation, and on the postoperative 1st day and 1st month.Peak systolic velocity (psv) and end-diastolic velocity (edv) were measured, and resistive index (ri) was calculated with the (psv-edv)/psv formula.Rdus parameters were compared before and after surgery and between ipsilateral and contralateral kidneys.Results: a total of 45 children with a median age was 8 (2¿17) years were included (15 (33.3%) girls, 30 (66.7%) boys).Pcnl was performed in 13 children (28.9%), rirs 11 (24.4%), urs 12 (26.7%), and ecirs 9 (20%).There was no significant difference in renal and segmental psv, edv and ri values of operated kidney in the preoperative, postoperative periods.There was no significant difference between rdus parameters of the ipsilateral and contralateral kidneys in preoperative or postoperative periods.Psv and edv values were significantly higher in the 1st postoperative month in the group without preoperative dj stent than in the group with dj stent (p = 0,031, p = 0,041, respectively).However, ri values were similar.The mean ri were below the threshold value of 0.7 in each period.Conclusion: rdus parameters didn¿t show a significant difference in children.Endoscopic surgeries can be safely performed in pediatric stone disease.Type of adverse events/number of patients penile edema (1 patient).Fever, positive blood culture, febrile convulsion, elevation in acute-phase reactants, and hemoglobin drop requiring erythrocyte sedimentation replacement (12 patients).
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6).The literature described "semi rigid ureteroscope (olympus 15 fr mini nephroscope with a 7-degree angled and 6 fr working channel)", so olympus selected ¿a37025a¿ as the representative model for this report.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: h6.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: KIT, NEPHROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22294870
• Report Number: 9610773-2025-04058
• Device Sequence Number: 15676758
• Product Code: FGA
• UDI-Device Identifier: 04042761023214
• UDI-Public: 04042761023214
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K853486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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
• Operator of Device: Health Professional
• Device Model Number: A37025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown