MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM 1 S 3D LAP, 0°

Model Number	26605AA
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the endoscope had an issue.The image was flickering black and white.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection was not possible.The failure description from customer image was flickering black/white.Based on the video sent in by the customer, it is clearly visible that the screen is flickering.Based on the customer's description of the fault, our own experience and the investigation of other complaints with similar fault patterns, the most likely cause here is that a component has failed that may have been damaged by a fall or the user, hence the image may fail or flicker as described by the customer.The event is filed under internal karl storz complaint id: (b)(4).
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
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).
Additional Manufacturer Narrative
Result of investigation: the customer's statement "image is flickering black/white" can be confirmed.After receiving the optics for further analysis, the following damage was found.The investigation revealed damage to the connection cable in relation to the flickering image.The connection cable has a cable break, which is most likely responsible for the flickering image.Furthermore, the control buttons are damaged.Mechanical damage in the form of impact marks and scratches can be seen in the distal area of the optics.The handle is also scratched.Scratches and impact marks can also be found on the optics shaft.The damage found cannot be attributed to a manufacturing/production defect.It is most likely that the damage was caused by clinical use/clinical preparation.At the time of the cause analysis, the operating hours read were 197.47 hours.No further measures will be taken.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: TIPCAM 1 S 3D LAP, 0°
• Common Device Name: TIPCAM 1 S 3D LAP, 0°
• 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: 21653703
• Report Number: 9610617-2025-00461
• Device Sequence Number: 15785027
• Product Code: FGB
• UDI-Device Identifier: 04048551347782
• UDI-Public: 04048551347782
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150525
• 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,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/31/2025

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: 26605AA
• Device Catalogue Number: 26605AA
• Device Lot Number: 13092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/07/2025; 04/14/2025; 05/02/2025; 07/23/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/11/2025; 04/17/2025; 05/22/2025; 07/31/2025
• 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
• Patient Sex: Unknown