MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.

Model Number	26053CB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All returned products were visually inspected and, where applicable, functionally tested.The devices exhibited varying degrees of wear and tear, in some cases significant.Based on the examination of the inner shaft with ceramic tip and the electrode, it was determined that ceramic fragments showed discoloration even at the fracture edges.This indicates that the ceramic tip fractured first, prior to the occurrence of the short circuit.The fracture of the ceramic tip allowed the electrode, when activated, to come into contact with the metal shaft, which subsequently caused the short circuit.The following concomitant medical products was returned on oct 15,2025: uh801 - bipolar high frequency cord, 400 cm.26120aa - hopkins telescope 0°, 2.9 mm, 30 cm (sn: (b)(6)).26053sc - resectoscope sheath, 15 fr.(lot: nn03).26053cd - telescope bridge (lot: zo01).26053oc - standard obturator (lot: zo02).26053eb - working element (lot: zo02).495nta - fiber optic light cable, 230cm, ø2.5mm (lot: zp17).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, during the procedure, operation was going fine.During cutting the polyp, there was a flash inside the patient and the loop unexpectedly disintegrated whilst in use, fragments embedded into the uterus wall.Some fragments were recovered.X-ray was taken.The patient will possibly have to have more surgery to fully remove fragments.Autocon iii on settings 2 con and 2 cut, uh801 bipolar cable use, with 4 uses left.Cross reference mdr: 9610617-2025-01826.

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Common Device Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23610533
• Report Number: 2020550-2025-02126
• Device Sequence Number: 21144566
• Product Code: HIH
• UDI-Device Identifier: 04048551410479
• UDI-Public: 04048551410479
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/20/2025
• Report Date (Section F): 11/20/2025

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: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: NN02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 26053CD - LOT: ZO01; 26053EB - LOT: ZO02; 26053OC - LOT: ZO02; 26053SC - LOT: NN03; 26120AA - SN:(B)(6) ; 495NTA - LOT: ZP17; UH400E - AUTOCON III 400 CE, 220-240V; UH801 - BIPOLAR HIGH FREQUENCY CORD, 400 CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown