MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM

Model Number	27026EF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "a bilateral ureteroscopy procedure was done.During the pre-disinfection of the instruments, it was noted that the tip of the albarran lever was missing, even though it is non-removable.After searching for the tip inside the patient using fluoroscopy, it was located within the patient.The patient was brought back to the operating room the same evening for removal of the tip, but in a different surgical suite".
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
The device in question was returned to the manufacturer.This information is reflected in section d9.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
Correction is provided in section d2b.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: during the manufacturer's technical inspection, the error description provided by the customer, "tip of the albarran lever was missing", could be confirmed.The steering has broken due to mechanical overload.All weld seams are broken and the material around the drill holes is also "torn open." this is a sign that excessive force has been applied.The article was manufactured in 2018, so corresponding signs of wear are also unavoidable.The above investigations did not reveal a root cause related to the labelling, the device, or its history.All production-related quality checks were passed, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any pickup in similar complaints; no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CATHETER DEFLECTING MECHANISM
• Common Device Name: CATHETER DEFLECTING MECHANISM
• 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: 22470841
• Report Number: 9610617-2025-01186
• Device Sequence Number: 4235035
• Product Code: ODB
• UDI-Device Identifier: 04048551231876
• UDI-Public: 04048551231876
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K943697
• 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): 12/19/2025

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: 27026EF
• Device Catalogue Number: 27026EF
• Device Lot Number: PR01
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/26/2025; 12/18/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/26/2025; 12/19/2025
• 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
• Patient Sex: Unknown