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

Model Number	26159SHW
Medical Device Problem Code	Pitted (1460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "at 09:30 on (b)(6) 2026, the patient underwent hysteroscopic surgery under intravenous anesthesia.The plan was to use a micro-scissor (hysteroscopic scissors) and a micro-forceps (hysteroscopic grasping forceps) to resect endometrial polyps.Following standard hysteroscopic surgical protocols for fine manipulation with specialized micro-instruments, preoperative inspection revealed significant rust on the surfaces of the micro-scissor and micro-forceps.Obvious rust stains were observed on key areas such as the instrument joints and cutting edges.The surgeon immediately switched to diagnostic curettage to resect the polyps; however, slight polyp residue remained, which was subsequently managed with oval forceps.The surgery was completed successfully, but the patient's operation time was prolonged.The rusted instruments were retained postoperatively as evidence." cross reference mdr 9610617-2026-1010.

• Brand Name: SCISSORS, POINTED, 5 FR., 34 CM
• Common Device Name: SCISSORS, POINTED, 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 ave; el segundo, CA 90245
• MDR Report Key: 25084863
• Report Number: 9610617-2026-01009
• Device Sequence Number: 10565488
• Product Code: GCJ
• UDI-Device Identifier: 04048551094471
• UDI-Public: 04048551094471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 26159SHW
• Device Catalogue Number: 26159SHW
• Device Lot Number: SP05
• 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: 04/23/2026
• Initial Report FDA Received Date: 05/05/2026
• 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