MAUDE Adverse Event Report: KARL STORZ SE & CO. KG EAR LOOP, SIZE 1

Model Number	152801
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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.Concomitant product added in section d10 device was inovlved in the event and did not defect involved component, which is not causal for the event: article: 400600 - nasal speculum, for children, 13 cm lot: ff03 product returned on: novemeber 10,2025.Cross reference complaint id (b)(4).The event is filed under internal karl storz complaint id:(b)(4).
Event or Problem Description
It was reported no defect description was provided for this case.But the technical inspection of the device showed that 3 loops were broken at the distal end.No negative impact in state of health reported.Cross reference mdr: 9610617-2025-02296, 9610617-2025-02297.

• Brand Name: EAR LOOP, SIZE 1
• Common Device Name: EAR LOOP, SIZE 1
• 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: 23783425
• Report Number: 9610617-2025-02295
• Device Sequence Number: 14734823
• Product Code: LRC
• UDI-Device Identifier: 04048551057643
• UDI-Public: 04048551057643
• 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
• Report Date (Section B): 12/11/2025

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: 152801
• Device Catalogue Number: 152801
• Device Lot Number: IL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE: 400600 NASAL SPECULUMLOT: FF03
• Patient Sex: Unknown