MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, BLUNT, 5 FR., 34 CM

Model Number	26159EHW
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
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 doctor was not able to excise the full lesion in the cervix because of the breakage of the instrument.This led her to revert to a d and c (dilation and curettage) so that the lesion could be excised completely.Prolongation of surgery was 30 minutes.Procedure was completed successfully and no negative impact in state of health reported".
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.This event is filed under internal complaint (b)(4).
Additional Manufacturer Narrative
Device evaluation: according to the customer, the scissors do not cut.However, as no item was returned, no investigation could be carried out.The most probable root cause of this could be that parts of the blade connection are damaged, which limits or eliminates the cutting action.Due to the age of the product (april 2017), this may also have a negative impact on the material properties.The above conducted investigations did not reaveal 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 pick up in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS, BLUNT, 5 FR., 34 CM
• Common Device Name: SCISSORS, BLUNT, 5 FR., 34 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21698754
• Report Number: 9610617-2025-00505
• Device Sequence Number: 18336319
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 04048551094280
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K935071
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26159EHW
• Device Catalogue Number: 26159EHW
• Device Lot Number: RS01
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 05/15/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/17/2025; 05/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown