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

Model Number	27050CA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ceramic beak had small chip with piece missing upon inspection in ep1 equipment audit.Issue was detected after procedure.No negative impact in state of health reported.As it cannot be excluded that the missing piece was lost in the patient a report is required precautionary.
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
Correction is made in section g3.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d4.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: according to the customer, the ceramic beak was broken during the procedure.This cannot be confirmed because no article was sent in for investigation.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pick up in similar complaints, no trend was identified.As the product itself has not been provided, no further investigations can be made.It is assumed that the ceramic insert broke due to the application of mechanical force.For example, it was pulled out of the shaft or the tip was struck.In this context, the instructions for use point out that damage to the shaft can have negative effects on the ceramic beak.Therefore, the instructions for use state that you should check the ceramic components for damage such as cracks, chipping, etc.Before each use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH FOR 27050 SC
• Common Device Name: INNER SHEATH
• 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: 21170533
• Report Number: 9610617-2025-00028
• Device Sequence Number: 4538627
• Product Code: FJL
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: UR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/05/2025; 01/20/2025; 03/26/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/16/2025; 01/21/2025; 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown