MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number	27040XA
Medical Device Problem Codes	Dent in Material (2526); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the clinic they had a sheath, reference 27404xa, and the ceramic bakelite was detached during surgery.They had to find an extractor and remove it.They were able to do so successfully without the patient being damaged.No death or (unanticipated) serious deterioration 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
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction in section h6 codes.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Based on the batch data, it was determined that the product was manufactured in may 2010 and had therefore been in use for around 16 years at the time of the incident.The visual inspection revealed several abnormalities, which taken together indicate age- and use-related weakening of the product structure.In particular, the combination of many years of mechanical stress, material fatigue, and repeated reprocessing and sterilization cycles appears to have gradually compromised the structural integrity of the adhesive bond between the ceramic part and the shaft.These influences may have led to the formation of microcracks or gaps at the joint, causing the adhesion to weaken progressively over time.In addition, we would like to call your attention to a warning in the corresponding instructions for use (document#: (b)(4), version v3.0_03/2019) on page 7.It describes that sheath with ceramic tips must be handled carefully.The sheaths must be checked for cracks or other damage each time they are used.Damaged sheath must never be used, since malfunctions could occur which could lead to patient injury.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Common Device Name: INNER SHEATH, FOR 27040 SD/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: 22666759
• Report Number: 9610617-2025-01316
• Device Sequence Number: 12669046
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 03/25/2026

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: 27040XA
• Device Catalogue Number: 27040XA
• 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: 09/01/2025; 03/16/2026; 03/18/2026
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/26/2025; 03/19/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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