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	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner sheath bayonet is easy to break in the process of use, and the subsequent operation cannot be carried out normally.No adverse consequences.Hospital inspection found that the internal sheath bayonet was easy to break during use, resulting in more product obsoletion, subsequent operations could not be carried out normally, but did not cause any human injury and adverse events.Cross reference mdr: 9610617-2024-00440.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference case id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection is not possible.The evaluation of the data provided revealed the following: pictures of the customer from the incoming email dated 31.10.2024 show clearly recognizable breakage of the inner shaft.The exact cause of the defect cannot be determined for article 27050xa (inner sheet, for 27050 sl) because the sheat is not provided to us despite multiple written requests for a cause analysis.It can be seen from the photo sent to us that the proximal end has inner broken parts.Therefore, an evaluation was created with the assumption of a broken connection.Internal karl storz reference number: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation on january 14,2025.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
Result of investigation: during the manufacturer's technical inspection of the returned product, the error description provided by the customer, " the inner sheath bayonet is easy to break in the process of use, and the hospital is damaged more, and the subsequent operation cannot be carried out normally", could be confirmed.The investigation shows that the corrosion and breakage damage to the item was mainly caused by insufficient drying after cleaning and repeated exposure to liquids.The manufacturer's instructions stipulate complete drying and regular visual inspection.If these specifications are not complied with, the responsibility lies with the user or the personnel performing the reprocessing.Only through consistent adherence to the cleaning and testing processes can the safety and functionality of the product be guaranteed.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,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr,-kark - storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20668145
• Report Number: 9610617-2024-00439
• Device Sequence Number: 8502656
• Product Code: HIH
• UDI-Device Identifier: 04048551078136
• UDI-Public: 04048551078136
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/06/2025

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
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 01/14/2025; 11/04/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/06/2024; 02/12/2025; 11/06/2025
• 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