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

Model Number	26159SHW
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the scissors break even when used once.No negative impact in state of health reported.Cross reference: mdr (b)(4).
Additional Manufacturer Narrative
The devices in question (26159shw, lot: pq03; (b)(6), lot: xl02; (b)(6), lot: nk04) were received by the manufacturing site in germany for investigation.The error described by the customer "scissors broken" could be confirmed.However, analysis of the instruments reveals severe corrosion, in particular pitting on the scissor blade and corrosion at the distal end.These types of damage are typical of multiple improper reprocessing cycles, especially when drying is insufficient.In combination with mechanical overuse, this can negatively affect material integrity and lead to breakage.The complaint is most likely due to improper handling and faulty reprocessing.The investigation did not reveal any root cause related to the device design, labeling, or manufacturing process.All quality control measures were met, and no non-conformities were found in the production records.In addition, we want to draw your attention to page 7 of the corresponding instruction for use (document id: 97000045_version: 2.0 - 10/2017)) which includes a warning under section 4.5 "assembly, inspection and care" advising to visually inspect the cleaned and disinfected medical device for cleanliness, completeness, damage and dryness.The event is filed under internal karl storz complaint id: (b)(4).

• 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: 22680024
• Report Number: 9610617-2025-01332
• Device Sequence Number: 18503520
• Product Code: GCJ
• UDI-Device Identifier: 04048551094471
• UDI-Public: 04048551094471
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 03/31/2026

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: NK04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 03/31/2026
• 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