MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 1.3 MM, SEMI-RIGID

Model Number	28160EK
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during a "ventriculocisternostomy" surgical procedure, the "scissors with one movable jaw," which were functional at the beginning of the operation, became non-functional midway through the procedure: they appeared to no longer open and were therefore removed from the surgical field.During the reprocessing phase at the time of pre-disinfection, it was discovered that one of the scissor blades was missing.Postoperative review of the procedure video: "no breakage of the device is visible in the ventricular cavities".No negative impact in state of health reported.
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).
Additional Manufacturer Narrative
Device evaluation: proximal shaft area damaged and corrosion a broken solder joint in the distal area between the shaft end and the jaw section was found.This could be caused by overloading, corrosion, or aging.The jaw section with the scissor blades is not damaged.The missing of one scissor blade could not be confirmed.Based on examination, the most probably root cause is a result of mechanical overload and aging of the solder joint.Based on the production date of march 2014, the product aging, reconditioning cycles, and corrosion weakened the solder joint, causing it to break under load.The missing of one scissor blade could not be confirmed.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS, 1.3 MM, SEMI-RIGID
• Common Device Name: SCISSORS, 1.3 MM, SEMI-RIGID
• 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
• MDR Report Key: 22333230
• Report Number: 9610617-2025-01096
• Device Sequence Number: 13010256
• Product Code: GWG
• UDI-Device Identifier: 04048551096642
• UDI-Public: 04048551096642
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982837
• 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,Followup
• Report Date (Section B): 01/16/2026

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: 28160EK
• Device Catalogue Number: 28160EK
• Device Lot Number: PV01
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 01/14/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/17/2025; 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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