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

Model Number	11102CM
Medical Device Problem Codes	No Display/Image (1183); Optical Problem (3001)
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.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
It was reported that the video-rhino-laryngoscope has no image and the surface on the tip is broken further, there is leakage fiberscope.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: a visual and functional test was carried out on the endoscope.The endoscope shows signs of wear and scratches.The steering mechanism rattles and scrapes.The vertebrae and the angle cover are mechanically damaged, causing the endoscope to leak.There is moisture in the housing.The sensor and the interface board are damaged by moisture.The "no image" error described by the customer was confirmed.This was caused by a mechanical impact that compressed and deformed the vertebrae and damaged the angle cover, causing it to leak.Moisture has entered the housing through the leaking angle cover.The ingress of moisture caused the sensor and the interface board to fail.For this reason, a user misuse error is to be assumed which led to the missing image.Endoscope bending section is heavily damaged, by excessive mechanical force, due to abnormal use.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 pickup in similar complaints, no trend was identified.According to the ifu (96056039d, version v3.1_01-2020) functionality should always be checked before every use to avoid injuries and damages to the product.Damaged scopes must not be used.It is described in detail how the scope must be handles stored correctly to avoid damage.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CMOS VIDEO RHINO-LARYNGOSCOPE
• Common Device Name: CMOS VIDEO RHINO-LARYNGOSCOPE
• 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: 21726585
• Report Number: 9610617-2025-00533
• Device Sequence Number: 17075829
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K182186
• 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
• Report Date (Section B): 06/30/2025

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: 11102CM
• Device Catalogue Number: 11102CM
• Device Lot Number: 100536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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