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).

• 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
• MDR Report Key: 24850208
• Report Number: 2020550-2026-00809
• Device Sequence Number: 5663806
• Product Code: EOQ
• UDI-Device Identifier: 04048551046982
• UDI-Public: 04048551046982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2026
• Report Date (Section F): 04/11/2026

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/01/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown