MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; Powered Laser Surgical Instrument

Model Number	27056LA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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).
Event or Problem Description
According to the information received, the tip where the laser fiber goes, the distal tip, came off inside the patient.The patient was not harmed and they were able to remove it.It slowed down the case since they had to go in to take it out.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
It was determined that both the product code and 510(k) number associated with this device were incorrect and have since been updated.Therefore, a correction supplemental was submitted to accurately reflect the current product code and 510(k) information.This event is filed under internal complaint id (b)(4).

• Brand Name: WORKING ELEMENT
• 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: 23344050
• Report Number: 9610617-2025-01841
• Device Sequence Number: 15817839
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 27056LA
• Device Catalogue Number: 27056LA
• Device Lot Number: RL01
• Date Returned to Manufacturer: 10/07/2025
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 10/20/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 213 LB