MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 27050XA

Model Number	27050XA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported 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.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 d4.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: 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 provided for a similar complaint (b)(4) show clearly recognizable breakage of the inner shaft.The exact cause of the defect cannot be determined for article (b)(4) (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.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the 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
Result of investigation: during the technical investigation of the returned product, the following was found: distal end: · damage to the ceramic beak with visible thermal effects.· cracks in the ceramic, likely due to thermal stress.Rear area of the item: · presence of contamination and corrosion.· material cracks indicating structural weakening.The combination of thermal damage and material cracks indicates that the item was either exposed to excessive thermal stress or improper use/cleaning.The corrosion observed could have been caused by insufficient drying or chemical influences during processing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: 27050XA
• Common Device Name: 27050XA
• 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: 20668131
• Report Number: 9610617-2024-00449
• Device Sequence Number: 8208325
• 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,Followup
• Report Date (Section B): 10/15/2025

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
• Device Lot Number: YM04
• 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: 11/20/2024; 12/02/2024; 01/07/2025; 10/09/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/21/2024; 12/05/2024; 01/14/2025; 10/15/2025
• 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