MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D

Model Number	26616ACA
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was imported into the us by medtronic netherlands, and then distributed to the customer (b)(6) hospital.We are submitting this medwatch on behalf of the manufacturer in germany.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 endoscope camera did not function and there was no image.A new endoscope was replaced to resolve the issue.There was a 5-minute delay.There was no patient injury.No negative impact in state of health reported.
Additional Manufacturer Narrative
Per investigation findings by the manufacturing site: the device was not sent to karl storz for inspection.A technical inspection regarding the error description provided by the customer, "no image," cannot be confirmed.A technical inspection and error analysis to determine the cause of the error in relation to the customer's description cannot be carried out because the item has not been returned.According to the customer, the tipcam is still in use.The evaluation revealed a single error.No further measures will be taken.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: TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D
• Common Device Name: TIPCAM1 RUBINA 0°, OPAL1 NIR/ICG, 4K 3D
• 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 ; 4242188247
• MDR Report Key: 23477135
• Report Number: 9610617-2025-02026
• Device Sequence Number: 16009670
• Product Code: OWN
• UDI-Device Identifier: 04048551426180
• UDI-Public: 04048551426180
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K212695
• 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): 03/09/2026

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: 26616ACA
• Device Catalogue Number: 26616ACA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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