MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR

Model Number	10101FA
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025 the part below from a prism came off during a bronch.No negative impact in state of health reported.The pieces were retrieved and checked for completeness.
Additional Manufacturer Narrative
It is unknown if the device will be returned to the manufacturing site for investigation.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the device in question was not returned to karl storz tuttlingen.Therefore, a technical inspection is not possible.Since no detailed error description and no lot code are available, it is not possible to perform a device history review.Investigation was performed based on the event description and pictures provided by the customer.According to the customer's description, parts of the prism headlight fell off during an intervention.This can be confirmed based on the images provided to us showing the fallen components.After comparing the individual parts visible in the customer's image with our 3d drawing, we can assume that all parts are present.The components are the latch with screw, pressure spring, and threaded pin.It is possible that the threaded pin came loose during use and clinical preparation, causing the individual components of the parts to fall off.We cannot determine whether this is a user error or a manufacturing defect, as the item has not been returned to us for closer inspection.The complaint history review did not reveal any similar complaints.No further action will be taken.This event is filed under internal complaint id 20253000222_981085.

• Brand Name: PRISMATIC LIGHT DEFLECTOR
• Common Device Name: PRISMATIC LIGHT DEFLECTOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21299512
• Report Number: 9610617-2025-00077
• Device Sequence Number: 18473525
• Product Code: EOQ
• UDI-Device Identifier: 04048551045244
• UDI-Public: 04048551045244
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10101FA
• Device Catalogue Number: 10101FA
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown