MAUDE Adverse Event Report: KARL STORZ SE & CO. KG HOPKINS TELESCOPE 12°, 4 MM, 30 CM

Model Number	26105FA
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: the patient entered the operating room at 08:40 on (b)(6) 2026, and routine preoperative preparation was performed.The lithotomy position was assumed at 09:00, followed by routine disinfection and draping.Transurethral vaporization resection of the prostate was formally initiated at 09:23.The primary surgical objective was to resect hyperplastic prostatic tissue to relieve the patient's urinary obstruction and related symptoms and improve prognosis.During the procedure, while using the high-frequency electrosurgical system to resect hyperplastic prostatic tissue, the resectoscope displayed a blurred image with ghosting shadows, severely obstructing the surgical field of view, which led to a surgical error causing prostatic bleeding in the patient, with an estimated blood loss of approximately 200 ml.The surgeon immediately used the resectoscope loop for electrocoagulation hemostasis, which was completed at 10:55.The patient's vital signs were monitored to ensure stability.Following the malfunction, a backup resectoscope was immediately replaced.The surgery concluded uneventfully at 11:30, and the patient was safely returned to the ward.Due to the mentioned prostatic bleeding and the corresponding blood loss, this case is deemed reportable.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• Common Device Name: HOPKINS TELESCOPE 12°, 4 MM, 30 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 25366159
• Report Number: 2020550-2026-01264
• Device Sequence Number: 10654655
• Product Code: HIH
• UDI-Device Identifier: 04048551093610
• UDI-Public: 04048551093610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2026
• Report Date (Section F): 06/02/2026

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: 26105FA
• Device Catalogue Number: 26105FA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2026
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown