MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, STRAIGHT, 2.5 MM, 55 CM

Model Number	10366S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: on sunday evening, during an esophageal foreign body operation, an otolaryngologist used an esophagoscope fine scissors to cut a fishbone in the esophagus.The scissors malfunctioned during use.After several unsuccessful attempts, the fine scissors were removed from the patient's body and tested on a surgical drape, which they also failed to cut.The scissors were then placed on the surgical instrument cart.After the operation was completed, the nurse found the instrument to be abnormally shaped during instrument retrieval and suspected a defect.She instructed the on-duty nurse to keep the instrument for further verification the next workday.By this time, the patient had been safely returned to the ward.On monday, the instrument nurse compared the oddly shaped instrument with photos taken during instrument packaging and confirmed that the distal tip of the scissors had broken off.The on-duty surgical nurse and operating surgeon were immediately notified, the surgical course was reviewed, and the incident was reported although the broken tip has not been recovered, retention of the fragment inside the patient has been ruled out.Due to the unknown whereabouts of the scissors distal tip, this case is deemed reportable for precautionary reasons.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the claimed product was not returned to karl storz tuttlingen.Therefore, physical technical inspection is not possible.Without a return, it is unfortunately not possible to classify the complaint in detail.Based on the customer's description (cutting through a fishbone during use), it is likely that the scissors broke; this was likely caused by excessive force, which can quickly lead to breakage due to the size of the scissors.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS, STRAIGHT, 2.5 MM, 55 CM
• Common Device Name: SCISSORS, STRAIGHT, 2.5 MM, 55 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: 24850210
• Report Number: 9610617-2026-00809
• Device Sequence Number: 5663808
• Product Code: EOQ
• UDI-Device Identifier: 04048551046982
• UDI-Public: 04048551046982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K943700
• 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
• Report Date (Section B): 05/08/2026

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: 10366S
• Device Catalogue Number: 10366S
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown