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

Model Number	27023TD
Medical Device Problem Code	Difficult to Open or Close (2921)
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.

• 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
• MDR Report Key: 21885249
• Report Number: 2020550-2025-00626
• Device Sequence Number: 12786795
• Product Code: FFL
• UDI-Device Identifier: 04048551390146
• UDI-Public: 04048551390146
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025
• Report Date (Section F): 04/14/2025

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
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 04/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown