MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ AIDA; Medical Device Data System

Model Number	WD300
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was not displaying image on the smartscreen, the unit did not turn off or on.No negative impact in state of health reported.
Additional Manufacturer Narrative
The device has been returned to our us facility and will be forwarded to the manufacturing site for investigation.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).
Additional Manufacturer Narrative
Manufacturer investigation completed.Per results of investigation: the customer complaint can be confirmed.During the investigation, it was determined that the responsible wiring harness was not in place and not in contact with the electrical component anymore.Based on the above-mentioned findings as well as based on the complaint history review, there is no indication for a manufacturing, material or design related failure.Furthermore, the corresponding ifu contains the information, that the product has to be checked before and after every use for functionality and damages.The most likely root cause for the complained failure is due to wear and tear.This event is filed under internal complaint id (b)(4).

• Brand Name: KARL STORZ AIDA
• Common Device Name: Medical Device Data System
• 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: 21526429
• Report Number: 9610617-2025-00374
• Device Sequence Number: 9584877
• Product Code: OUG
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2026

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: WD300
• Device Catalogue Number: WD300
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 09/04/2026
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/23/2025; 09/17/2026
• 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