MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STONE BASKET, 2.5 FR., TIP, HELICAL

Model Number	27023TD
Medical Device Problem Codes	Difficult to Open or Close (2921); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the first stone was removed during urs without any problems.However, when attempting to remove the second stone, the basket of the stone basket could not be closed and the stone could not be removed.The stone basket was pulled out in an open state.There was no replacement device available on site, so major surgery was performed immediately.The patient was under anesthesia for a longer period of time and underwent major surgery immediately afterwards.The user changed the procedure from endoscopic to surgical.The procedure took 90 minutes longer, but the dog was able to go home the same day.".
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction to b2.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
According to the error description from the customer, a first stone was removed during urs (veterinary procedure on a dog) without any problems.However, when attempting to remove a second stone, the basket of the stone basket could not be closed and the stone could not be removed.During inspection of the returned product it was found that the outer cover has been plastically deformed in several places.Due to the deformation of the cover, the stone trap basket is firmly enclosed and its function (sliding back and forth) is no longer possible.Based on the deformations found on the cover of the returned product, it is concluded that the most probable causes are application of too much pressure/force during use or coming into contact with a hot surface or too hot environmental conditions.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: STONE BASKET, 2.5 FR., TIP, HELICAL
• Common Device Name: STONE BASKET, 2.5 FR., TIP, HELICAL
• 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
• MDR Report Key: 21965201
• Report Number: 9610617-2025-00787
• Device Sequence Number: 15557189
• Product Code: FFL
• UDI-Device Identifier: 04048551390146
• UDI-Public: 04048551390146
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27023TD
• Device Catalogue Number: 27023TD
• Device Lot Number: 35563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 05/16/2025; 09/06/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/14/2025; 05/28/2025; 09/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown