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

Model Number	27056LA
Medical Device Problem Codes	Material Fragmentation (1261); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instruments broke off during use.The surgeon was able to end the surgery in a normal way, without any delay.There were no consequences for the patient.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Investigation: examination of the items subject to complaint indicates that the fractures observed are most likely not attributable to a manufacturing defect.In both cases, significant corrosion damage and structural defects were identified, which significantly weakened the material.The advanced age of the instruments, the possible exceeding of their intended life cycle, and inadequate reprocessing and drying processes are significant contributing factors.In addition, the damage patterns indicate that mechanical overload and inadequate visual inspection prior to use cannot be ruled out.Overall, the available findings suggest that the damage was caused by a combination of material fatigue, corrosion and user errors.Consistent compliance with the ifu and reprocessing instructions is crucial to ensure the functionality and safety of the instruments throughout their entire life cycle.The event is filed under internal karl storz 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 avenue; el segundo, CA 78532 ; 4242188247
• MDR Report Key: 21664278
• Report Number: 9610617-2025-00486
• Device Sequence Number: 15346998
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2026

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: WH34
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 04/07/2025; 02/27/2026; 09/04/2026
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/02/2025; 03/06/2026; 10/02/2026
• 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