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

Model Number	26159EHW
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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
It was reported that a procedure was incomplete because it was not possible to collect material for biopsy, a new date has been scheduled for the procedure.Since the new procedure have to be scheduled, this case is reportable.
Additional Manufacturer Narrative
The device in question was returned manufacturer.This information is reflected in section d9.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).
Additional Manufacturer Narrative
The product was returned for evaluation.Upon inspection, heavy corrosion was observed, particularly on the distal end of the device.In addition, the inner pull rod on the proximal side was found to be damaged or broken, rendering the scissors non-functional.· the observed corrosion and breakage are consistent with long-term exposure to moisture or improper cleaning and sterilization practices.· there was no evidence of any issues related to the labeling, device design, or manufacturing history.The failure of the device is most likely attributed to corrosion-related material degradation, possibly due to insufficient maintenance or improper reprocessing over time.No manufacturing defects were identified during the investigation.Users are reminded to follow the ifu closely, particularly with regard to cleaning, drying, and inspecting instruments after each use to prevent corrosion and ensure continued device performance.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
• 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: 20315466
• Report Number: 9610617-2024-00322
• Device Sequence Number: 12682261
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 04048551094280
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 06/25/2025

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: OM02
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 05/16/2025; 06/13/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 05/30/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown