MAUDE Adverse Event Report: KARL STORZ SE & CO. KG GRASP. FORCEPS,Ø3.5 MM,NL 36 CM,90°AOV

Model Number	28163FZ
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reportated during the procedure, the grasper broke.There was no impact to the patient or user.
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).
Additional Manufacturer Narrative
Accordingly, we would like to give a summary of our results regarding the reported issue.The evaluation results: the complained product was not returned for inspection.Based on the customer's description of the defect, the jaw plate[?]or a portion of it is broken.The most likely cause is overloading, which led to the breakage.Since it can be assumed that the item has undergone numerous applications and reprocessing cycles commensurate with its age, this may have had a negative impact on the material properties.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: GRASP. FORCEPS,Ø3.5 MM,NL 36 CM,90°AOV
• Common Device Name: GRASP. FORCEPS,Ø3.5 MM,NL 36 CM,90°AOV
• 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: 22966992
• Report Number: 9610617-2025-01546
• Device Sequence Number: 15718740
• Product Code: HRX
• UDI-Device Identifier: 04048551265260
• UDI-Public: 04048551265260
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K955272
• 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
• Report Date (Section B): 03/27/2026

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: 28163FZ
• Device Catalogue Number: 28163FZ
• Device Lot Number: YO01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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