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.".
Additional Manufacturer Narrative
Additional information added in section b5 cross reference complaint id:(b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Cross reference mdr: 9610617-2026-00556.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• 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: 24576043
• Report Number: 9610617-2026-00538
• Device Sequence Number: 21413986
• Product Code: EOQ
• UDI-Device Identifier: 04048551047613
• UDI-Public: 04048551047613
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 04/01/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 03/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/03/2026
• 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