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	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "stone extractor did not open during urs and could not be removed.No backup device on site and further treatment of the dog in clarification.The patient was under anesthesia for a longer period of time and follow-up treatment is necessary.The user changed the procedure; the stone was flushed into the bladder using a catheter and now the further procedure is being coordinated with the patient's owner.It is not yet possible to say which indication is the best solution.The procedure took about 30 minutes longer, but the dog was able to go home the same day." according to the received information, the concerned instrument (27023td - stone basket, 2.5 fr., tip, helical) was used in a veterinary procedure on a dog.The procedure could not be completed successfully.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that "stone extractor did not open during urs and could not be removed.No backup device on site and further treatment of the dog in clarification.The patient was under anesthesia for a longer period of time and follow-up treatment is necessary.The user changed the procedure, the stone was flushed into the bladder using a catheter and now the further procedure is being coordinated with the patient's owner.It is not yet possible to say which indication is the best solution.The procedure took about 30 minutes longer, but the dog was able to go home the same day." according to the received information, the concerned instrument (27023td - stone basket, 2.5 fr., tip, helical) was used in a veterinary procedure on a dog.The procedure could not be completed successfully.
Additional Manufacturer Narrative
Result of investigation: according to the error description from the customer, the stone extractor did not open during urs (veterinary procedure on a dog) and 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, 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.As stated above, this case happened during use in a veterinary procedure.There is only one similar case known, which also happened during veterinary procedure and with the same customer.There are no known comparable complaints with article 27023td during use on a human patient.Therefore, these cases are considered as isolated veterinary events, and no critical or systematic trend could be identified.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: 21886246
• Report Number: 9610617-2025-00626
• Device Sequence Number: 8189940
• 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
• Report Date (Section B): 08/08/2025

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: 35499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown