MAUDE Adverse Event Report: KARL STORZ SE & CO. KG GRASPING FORCEPS, 3 FR.

Model Number	11274FE
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer on february 19,2025.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).
Event or Problem Description
It was reported in the beginning of the surgery, the clamp worked correctly, but during the surgery, the clamp stopped closing with the force that it was initially doing.So, the doctors had to change the clamp during surgery.This was what caused the prolongation 20-25 min of it.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: the investigation of the returned product revealed that the joint of the pliers is broken, which means that it can be no longer opened or closed.At the point of breakage, it can be seen that the material is bent to the right, which is a sign that the material has given way due to excessive force.This is caused by mechanical overloading of the connection point.For example, it can occur when gripping unintended material.All production related quality checks were passed, and no non-conformities were identified in the devices manufacturing records.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: GRASPING FORCEPS, 3 FR.
• Common Device Name: GRASPING FORCEPS, 3 FR.
• 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: 21470504
• Report Number: 9610617-2025-00312
• Device Sequence Number: 19685576
• Product Code: OCZ
• UDI-Device Identifier: 04048551050545
• UDI-Public: 04048551050545
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: D013453
• 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
• Report Date (Section B): 04/15/2025

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: 11274FE
• Device Catalogue Number: 11274FE
• Device Lot Number: YL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/14/2025
• Was Device Evaluated by Manufacturer? (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
• Patient Sex: Unknown