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

Model Number	11102CM
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
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
It was reported that equipment does not display image.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information is provided in section b5 and d10.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
New information received on (b)(6) 2025 that the customer reported the following additional details: the flexible endoscope (11102cm) worked great but they connected it for internal training team, the telepack (tp101) did not display the image.The malfunction occurred during internal training, no associated procedure, no patient involvement.The initial assessment as reportable malfunction is not impacted.
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: 11102cm / cmos video-rhino-laryngoscope, 2.9 mm: the device was returned on 03.03.2025.A visual and functional test was carried out on the endoscope.The endoscope has a cut and a bruise in the shaft and the distal head is deformed, causing the bonding to come loose and the head to leak.The vertebrae are deformed, and a rivet is missing.The angle cover is perforated.The fixing nut of the lever is scratched, which could be an indication of a third-party repair.The sensor is damaged so there is no image.The causes of these problems are due to usage errors or/and wear.The labelling was found to contain adequate instructions and warnings.Tp101 / tele pack +: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection was not possible.Due to the several defects of product 11102cm it could be assumed, that product tp101 is not causative to the described failure.Summary: the error described by the customer " the equipment does not display image" could be confirmed and assigned to product 11102cm.The cause of the image failure is that the vertebrae distal link is deformed and rivet missing.At this place image sensor flex pcb damaged, what caused image failure.For this reason, a user misuse error is to be assumed which led to the missing image.The failure of the image is not due to a production error.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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21644465
• Report Number: 9610617-2025-00463
• Device Sequence Number: 7574169
• Product Code: EOB
• UDI-Device Identifier: 04048551402405
• UDI-Public: 04048551402405
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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,Followup,Followup
• Report Date (Section B): 05/06/2025

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: 11102CM
• Device Catalogue Number: 11102CM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 04/14/2025; 01/11/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/20/2025; 04/17/2025; 05/06/2025
• 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: TP101.
• Patient Sex: Unknown