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

Model Number	WD300
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our us facility on jan-30-2025, and will later 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).
Event or Problem Description
It was reported that during a procedure on (b)(6) 2025 (case type information was not provided), the recording device image cut off and the screen goes black.The device then shut off itself and cannot be restarted.Since this device is recording device, they were still able to complete the procedure using the main or monitor without any patient impact,.
Additional Manufacturer Narrative
The device was sent to the manufacturer for inspection.During the manufacturer's technical inspection, the error description provided by the customer," reported issue: the image cuts off and the screen goes black.The last time the unit was used on (b)(6) 2025, it was during patient use.The aida shut off in the middle of the case and could not be restarted after." couldn't be confirmed.No malfunction present.Device functions perfectly according to specifications.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: 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: 21329609
• Report Number: 9610617-2025-00153
• Device Sequence Number: 18257106
• Product Code: OUG
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• 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: 01/30/2025
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 09/04/2026
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 12/12/2025; 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