MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NASAL FORCEPS, STRAIGHT, SIZE 0, 11 CM

Model Number	456000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.
Event or Problem Description
It was reported that the veterinary surgeon had to stop the intervention for 10 minutes as three of them broke directly during an operation, and do not have the same "hold" as the previous ones i had been able to buy.Considering the purchase price, it is expensive to break them so easily.They always break in the same place.'' no death or (unanticipated) serious deterioration in state of health reported.Cross reference mdr: 9610617-2025-00119, 9610617-2025-00117.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
An incorrect address was provided in section g1 in the initial report.This supplemental report is to provide the correct contact information for this section.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Adding awareness date for 9610617-2025-00118 supplemental #2, as it was submitted without the awareness date.The awareness date should be april 14,2025.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Result of investigation: examination of the instruments sent in shows an identical fracture at the transition between the shaft and the jaw part on all three products.The smooth fracture structure indicates the application of excessive force.An assembly error can be ruled out, since both attachment points are affected on all instruments.According to the warnings in the instructions for use, excessive mechanical stress can increase the risk of malfunctions and material failure, which can lead to potential hazards for patients and users.It is also strongly recommended that instruments be checked for damage and full functionality before each use, and that damaged instruments be replaced immediately.Based on this information, a misapplication due to excessive force or insufficient visual inspection before use is to be assumed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: NASAL FORCEPS, STRAIGHT, SIZE 0, 11 CM
• Common Device Name: NASAL FORCEPS, STRAIGHT, SIZE 0, 11 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 ; 4242188247
• MDR Report Key: 21300125
• Report Number: 9610617-2025-00118
• Device Sequence Number: 20838077
• Product Code: LRC
• UDI-Device Identifier: 04048551163962
• UDI-Public: 04048551163962
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/27/2025

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: 456000
• Device Catalogue Number: 456000
• Device Lot Number: XL02
• 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: 01/18/2025
• Supplement Date Received by Manufacturer: 02/07/2025; Not provided; 04/14/2025; 05/19/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/03/2025; 04/14/2025; 04/15/2025; 05/30/2025
• 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