MAUDE Adverse Event Report: KARL STORZ ENDOVISION CMOS VIDEO-RHINO-LARYNGOSCOPE

Model Number	11101CM
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 "endoscope can transmit light from the c-mac but cannot display an image.Another endoscope works.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: a visual and functional test was carried out on the endoscope.The handle and the housing show signs of wear, impact marks and scratches.There is residue on the angle cover.The angle cover is torn approx.8mm from the distal end and is therefore leaking.There is moisture in the housing and on the interface board, causing sensor damaged.The angel cover was cut open during the evaluation.The error described by the customer " no image no light" could be confirmed.This was caused by moisture ingress, which damaged the sensor and the interface board.Moisture entered the endoscope through the torn angle cover, damaging the electronics.For this reason, a user misuse error is to be assumed which led to the missing image.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 endoscope has been locked since (b)(6) 2020 the complaint history did not reveal any pickup in similar complaints, no trend was identified.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 ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 91 carpenter hill road; charlton,, MA 01507
• MDR Report Key: 23019200
• Report Number: 1221826-2025-01572
• Device Sequence Number: 18598081
• Product Code: EOB
• UDI-Device Identifier: 04048551260128
• UDI-Public: 04048551260128
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103467
• 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): 10/06/2025

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: 11101CM
• Device Catalogue Number: 11101CM
• Device Lot Number: 13304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/06/2025
• 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
• Patient Sex: Unknown