MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR; A37025A

Model Number	A37025A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Sepsis (2067); Septic Shock (2068); Ventilator Dependent (2395)
Date of Event	05/05/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient underwent cystoscopy and holmium laser or both penile and bulbar urethral strictures, complex urethral dilation, placement of a foley catheter, removal of the artificial urinary sphincter, and placement of a suprapubic cystostomy tube.After the procedure was performed, staff found that the 11 french 7-degree pediatric cystoscope (the only scope that could pass through proximal penile urethral stricture) was slightly bent.Patient recovered well with minimal bleeding in post anesthesia care unit (pacu) and was discharged home with no complications.The patient later reported waking up at home to find bed saturated with blood.The patient went to local emergency room and was subsequently transferred back to the facility with anemia and hypotension.The patient was placed on pressors, ventilated, and treated for sepsis.Patient was then transferred to a higher level of care for procedures unable to be performed at the facility.Customer notes that it is unknown whether the device is related to outcomes.E2 - health professional: was unable to be changed for no but should be yes.Since the device described was a "11 french 7-degree pediatric cystoscope", we selected "(b)(6)" as a representative product.
Event or Problem Description
Additional information received the patient was re-admitted to the facility, received blood transfusions, was treated for septic shock, and was administered the antibiotics zosyn and linezolid.The patient was subsequently transferred for sledd (sustained low-efficiency daily dialysis) and has since expired.This supplemental report is being submitted to update fields (a2, a3, a4, a5, a6, b1, b2, b5, b7, f6, f10) and attach the related medwatch report.Additionally, this supplemental report is providing further information shared by the customer.
Event or Problem Description
Additional information was received from the customer indicating that the patient was re-admitted to a different facility for treatment of an infection.The patient subsequently expired at that facility, and it is unknown whether an autopsy was performed.The customer indicated that they did not consider the patient¿s death to be related to the device.This supplemental report is being submitted to update fields (b5 and f9) and additional information provided by the customer.

• Brand Name: OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULAR
• Common Device Name: A37025A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 22161432
• Report Number: 2429304-2025-00173
• Device Sequence Number: 8907124
• Product Code: FGA
• UDI-Device Identifier: 04042761023214
• UDI-Public: 04042761023214
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2025
• Report Date (Section F): 09/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A37025A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/05/2025
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/03/2025; 09/03/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 09/03/2025