MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FORCEPS, 5 FR., 60 CM

Model Number	27425F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9 it was returned on december 23,2025.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).
Event or Problem Description
It was reported during the operation, when grabbing the stone, the connection of the branches with thrust was damaged.The replacement was used in 5-10 minutes.The procedure was completed without any patient injury or harm, there was no patient injury.No patient involvement and procedure delay less than 15 mins.Cross reference mdr: 9610617-2025-00139.
Event or Problem Description
New information was provided that states two patients were involved in this event.
Additional Manufacturer Narrative
Additional information is provided in section b5.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The pliers show severe corrosion at the proximal connection point and in the jaw area, which may indicate improper reprocessing.Additionally, excessive mechanical strain on the jaws could have led to breakage or loosening at the connection point.The investigation did not reveal any root cause related to the labelling, the device, or its history.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FORCEPS, 5 FR., 60 CM
• Common Device Name: FORCEPS, 5 FR., 60 CM
• 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: 21318166
• Report Number: 9610617-2025-00137
• Device Sequence Number: 18174847
• Product Code: OCZ
• UDI-Device Identifier: 04048551083185
• UDI-Public: 04048551083185
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: K950434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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: 27425F
• Device Catalogue Number: 27425F
• Device Lot Number: W UN03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 02/07/2025; 09/19/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/19/2025; 10/10/2025
• 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
• Patient Sex: Unknown