MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS

Model Number	27290SA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the blade broken on one side.No negative impact in state of health reported.
Additional Manufacturer Narrative
Device evaluation: as no article was sent in for inspection, no in-depth investigation can be carried out.As can be seen in the customer's photos, corrosion/residue is visible in the area of the jaw joint.This could have a negative effect on the material.In addition, mechanical overload cannot be ruled out.There are no known comparable complaints, so this can be assumed to be an isolated defect.The above conducted investigations did not reveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The complaint history did not reveal any similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS
• Common Device Name: SCISSORS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 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: 22099009
• Report Number: 9610617-2025-00928
• Device Sequence Number: 20704719
• Product Code: FGA
• UDI-Device Identifier: 04048551082546
• UDI-Public: 04048551082546
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K232370
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 27290SA
• Device Catalogue Number: 27290SA
• Device Lot Number: UL02
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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