MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SL

Model Number	27050XA
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the surgeon noticed that the item is broken, in the proximal side that is near the connection to the working element.He replaced the inner sheath with a similar item from another available set and completed the operation.At the end of the operation, the bladder was examined as part of the operation process, and it was observed to be clean with no external parts.The surgeon informed us that there was no additional time for the operation (except for about a minute to replace the broken component).No harm was caused to the patient there was no change in the treatment/hospitalization protocol.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation on may 7, 2025.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer, " the surgeon claims that during the procedure, he noticed that the item is broken, in the proximal side that is near the connection to the working element", could be confirmed.The damage found on the item with lot uq10 (manufactured in july 2019) - in particular the breakage of the ceramic tip at the distal end and the breakage of the shaft in the proximal area - can be clearly attributed to a combination of mechanical overload and possible age- or usage-related pre-existing damage.The manufacturer's documentation (see ifu: 97000126 v3.0_03/2019 page 2, 3 and 7) expressly points out that ceramic tips are sensitive and can break even as a result of microcracks that can occur during use or due to improper handling.The age of the item can also contribute to such pre-existing damage.According to the instructions, damaged ceramic tips must not be used further under any circumstances.The proximal shaft fracture indicates that excessive force was applied, as the shaft tends to bend or deform under normal stress, but does not break.In summary, it can be concluded that the damage is due to non-compliant handling and/or excessive mechanical stress.Age- and usage-related damage, especially to the ceramic tip, can further increase the risk of breakage.The responsibility for the defects lies with the user or the reprocessing staff if the manufacturer's instructions were not followed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SL
• Common Device Name: INNER SHEATH FOR 27050 SL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21919997
• Report Number: 9610617-2025-00709
• Device Sequence Number: 18400003
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27050XA
• Device Catalogue Number: 27050XA
• Device Lot Number: UQ10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 03/12/2026
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/27/2025; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown