MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER TUBE FOR 27040 SD/SL; Powered Laser Surgical Instrument

Model Number	27040XAL
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
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 returned to our us facility, 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).Cross reference complaint id (on the 27068cd bridge as a coconmitant item): (b)(4).
Event or Problem Description
It was reported that "combination of 27040xal and 27068cd bridge caused poor image on screen".It was confirmed that there was no patient injury or impact due to the reported issue and the surgeon was able to complete the procedure without delay.No negative impact in state of health reported.Cross reference complaint id (on the 27068cd bridge as a coconmitant item): (b)(4).

• Brand Name: INNER TUBE FOR 27040 SD/SL
• Common Device Name: Powered Laser Surgical Instrument
• 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: 23281755
• Report Number: 9610617-2025-01785
• Device Sequence Number: 15664475
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K230535
• 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
• 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: 27040XAL
• Device Catalogue Number: 27040XAL
• Device Lot Number: OK01
• Date Returned to Manufacturer: 10/13/2025
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 09/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 27068CD__DATE CODE RU03
• Patient Sex: Male