MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL FORCEPS, WITH ALLIGATOR JAWS

Model Number	10378HF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
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
The following was reported: "during a bronchoscopy, the instruments were damaged trying to remove a foreign object.Due to the complexity of the case extra force was required, which is why we believe the instruments were damaged.Case aborted due to complexity, not the kit.The case was a difficult bronchoscopy where the patient had a thumb pin stuck in their airway.The pin was lodged in the patient and potentially too heavy for the grasper, causing the grasper to break.".

• Brand Name: OPTICAL FORCEPS, WITH ALLIGATOR JAWS
• Common Device Name: OPTICAL FORCEPS, WITH ALLIGATOR JAWS
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 24576040
• Report Number: 2020550-2026-00538
• Device Sequence Number: 21413985
• Product Code: EOQ
• UDI-Device Identifier: 04048551047613
• UDI-Public: 04048551047613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/11/2026
• Report Date (Section F): 03/11/2026

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: 10378HF
• Device Catalogue Number: 10378HF
• Device Lot Number: ZN01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2026
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• 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