MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CMOS VIDEO RHINO-LARYNGOSCOPE SSU

Model Number	091330-06
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the scope would not power on prior to case.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection the customer complaint "the scope would not power could be confirmed.The defect is to be found somewhere in the signal chain - sensor, flex print, pcb and supply cable.Due to the fact, that the camera head and led is casted into the tip assembly, no further investigation was possible.It either can be a production issue or it got damaged during removal from the sterile packaging.The above 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 device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.This event is filed under internal complaint id: (b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE SSU
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 22104777
• Report Number: 9610617-2025-00941
• Device Sequence Number: 17922780
• Product Code: EOB
• UDI-Device Identifier: 04048551417331
• UDI-Public: 04048551417331
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 091330-06
• Device Catalogue Number: 091330-06
• Device Lot Number: 500110552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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