MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CATHETER DEFLECTING MECHANISM; RIGID ENDOSCOPE WORKING GUIDE

Model Number	27026EF
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that the end of the device, which was rotatable, broke off in the patient's bladder and was only noticed when another endoscope was inserted.This prolonged the operation as the surgeon had to try to fish out the foreign body and the patient's bladder.The user's report to the local authority also indicates, on the basis of the selected imdrf codes, that there was a urinary tract infection and an unspecified kidney or urinary problem.No detailed information is available on this.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on (b)(6) 2024.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
The product was returned on 2024-11-27.The investigation of the product was completed on 2025-01-21.The reported issue could be confirmed.The connection of the two tie rods at the transition to the lever has come loose/broken.The article was already produced in march 2012, so it can be concluded that it has been reprocessed a corresponding number of times.The corrosion found may have occurred, for example, due to incorrect processing, not being completely dried.Since corrosion has a negative effect on the material properties, the material is weakened as a result.It is likely that the connection could not withstand the mechanical overload and broke.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CATHETER DEFLECTING MECHANISM
• Common Device Name: RIGID ENDOSCOPE WORKING GUIDE
• 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: 20789058
• Report Number: 9610617-2024-00462
• Device Sequence Number: 15177285
• Product Code: ODB
• UDI-Device Identifier: 04048551231876
• UDI-Public: 04048551231876
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2025

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: 27026EF
• Device Catalogue Number: 27026EF
• Device Lot Number: PX08
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 11/27/2024; 01/21/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown