MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NEEDLE, TONSIL, STRAIGHT, LONG

Model Number	810502
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
According to the information received tip blunt/broken.No negative impact in state of health reported.
Additional Manufacturer Narrative
Investigation: the device was returned to the manufacturer for evaluation.During the technical inspection, the customer's reported issue ("tip blunt/broken off") was confirmed.The tip of the cannula had fractured.Based on the condition of the component, it is likely that the breakage resulted from mechanical impact.Due to the small dimensions of the cannula, careful handling is required.There is no indication that the cannula fractured during use, and no similar complaints were reported during the relevant period.The investigation did not identify any root cause related to the device design, labelling, or production history.All manufacturing and quality control records were reviewed and showed no non conformities.The labelling was verified to contain appropriate instructions and warnings.A review of the complaint history revealed no increase in comparable cases, and no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: NEEDLE, TONSIL, STRAIGHT, LONG
• Common Device Name: NEEDLE, TONSIL, STRAIGHT, LONG
• 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: 22194831
• Report Number: 9610617-2025-01008
• Device Sequence Number: 9310982
• Product Code: LRC
• UDI-Device Identifier: 04048551203828
• UDI-Public: 04048551203828
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 05/08/2026

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: 810502
• Device Catalogue Number: 810502
• Device Lot Number: PK01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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