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

Model Number	R26159EHW
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that a piece broke off in patient while performing a hysteroscopy, were able to retrieve the broken piece without harm to the patient.No negative impact in state of health reported.
Additional Manufacturer Narrative
Updated section d9 to yes, and entered the device returned date to the manufacturer.The device was returned to our us facility on april 22, 2025.It will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Correction made to section h6 for component code (g) and investigation conculsion (d) this event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: a connecting rivet has come loose in the joint on the distal side.This is due to a manufacturing defect (investigation carried out by the supplier).The weld seam on the back part was not deep enough.An employee did not drill the hole deep enough.This event is filed under internal 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, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21766321
• Report Number: 9610617-2025-00551
• Device Sequence Number: 12930708
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 04048551094280
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2026

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: R26159EHW
• Device Catalogue Number: R26159EHW
• Device Lot Number: OL02
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 02/09/2026; Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/24/2025; 02/19/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female