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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a inner sheath broke during procedure.The customer has reported that this occurred during the procedure and it is likely that the surgeon broke this whilst maneuvering the sheath and telescope.No part was falling in the patient.No negative impact in state of health reported.
Additional Manufacturer Narrative
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
Device evaluation: accordingly, we would like to give a summary of our results regarding the reported issue.The device shows that the proximal end of the shaft has mechanical break points.The fault description provided by the customer was confirmed.The investigation revealed that the damage to the shaft and the breakage of the plastic parts on the back of the product were caused by mechanical overload.According to the manufacturer's instructions (see dcd218_en_v1.1_ifu_ce-mdr.Pdf, chapters 3.2 and 3.4), the products must not be subjected to excessive mechanical force and bent parts must not be bent back into their original shape.Damage such as breakage or chipping is usually caused by improper handling, for example, by applying excessive force during assembly, use, or transport.Responsibility for such damage lies with the user or reprocessing personnel if the product is not handled in accordance with the instructions.Only through proper use and regular inspection for mechanical defects can the functionality and safety of the product be ensured.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: 22579478
• Report Number: 9610617-2025-01269
• Device Sequence Number: 7985922
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: UW05
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 02/24/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/23/2025; 03/03/2026
• 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