MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CYSTOSCOPE SHEATH, 22 FR.

Model Number	27026B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
"2nd cystoscopy sheath (tv05) used on patient and broke whilst in the patient - consultant tried to remove the sheath +++ times with forceps, catheters - used rigid and flexible approach in order to try and remove the broken fragment of sheath".And in a further description it was stated "sheath broke off and consultant unable to remove fragment from patient despite trying ample times.Sheath still remains in patient and unable to complete planned operation surgeon unable to remove sheath from patient, despite trying, patient has since undergone a second procedure to remove the fragment which has also been unsuccessful.Patient was stable post op but had to be transferred to another hospital facility in order to receive appropriate care such as potentially needed a suprapubic catheter which we cannot provide.

• Brand Name: CYSTOSCOPE SHEATH, 22 FR.
• Common Device Name: CYSTOSCOPE SHEATH, 22 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21856673
• Report Number: 2020550-2025-00594
• Device Sequence Number: 7888791
• Product Code: ODB
• UDI-Device Identifier: 04048551074138
• UDI-Public: 04048551074138
• 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): 04/16/2025
• Report Date (Section F): 04/16/2025

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: 27026B
• Device Catalogue Number: 27026B
• Device Lot Number: TV05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/17/2025
• 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: Hospitalization
• Patient Sex: Unknown