MAUDE Adverse Event Report: KARL STORZ SE & CO. KG NASAL FORCEPS, 45°, 3.5 MM, 11 CM

Model Number	456121
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.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
According to the information received, the product had a cutting defect during the first use after delivery (tissue tearing).A prolongation of less than 15 min was reported and no adverse consequences.
Additional Manufacturer Narrative
Device evaluation: during the examination of the returned product, it was determined that the cutting edge is blunt.The outgoing goods inspection could not detect any irregularities.Therefore, it must be assumed that the scissors were damaged during use.For example, by cutting materials not intended for the purpose, the jaw part was bent.This resulted in deformation of the cutting edge and as a result the shearing function is no longer given.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Correction is made in section g3.The aware date in the initial report was incorrect.The correct aware date for this event was october 22, 2024.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: NASAL FORCEPS, 45°, 3.5 MM, 11 CM
• Common Device Name: NASAL FORCEPS
• 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: 20833540
• Report Number: 9610617-2024-00490
• Device Sequence Number: 11741841
• Product Code: LRC
• UDI-Device Identifier: 04048551164136
• UDI-Public: 04048551164136
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 456121
• Device Catalogue Number: 456121
• Device Lot Number: PL04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 12/19/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 12/06/2024; 12/27/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown