MAUDE Adverse Event Report: KARL STORZ SE & CO. KG D-LIGHT P HIGH POWER LIGHT UNIT FOR AF; LIGHT SOURCE

Model Number	20133720-1
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should 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).
Event or Problem Description
Customer reported that during a procedure, the device caught on fire; no patient injury.
Additional Manufacturer Narrative
Per new information from the certified perioperative nurse (cnor), this incident was found prior to a patient being brought in to the or.They were setting up the or for an arthroscopy case and upon noticing the foul odor, or determined that the light source was the issue.The unit was then removed and replaced with a unit from another or prior to the patient being brought back to surgery.No delay in surgery occurred.Also per the cnor, no flame or spark was noted with the incident.When the light bulb assembly was removed, it was noted to have the burnt appearance.No one was injured when handling this.It was reported that the device caught fire during the procedure, with no harm to patient or user reported.Initially, this case was deemed to be reportable since the reported issue could lead to a serious injury in case of reoccurrence; however, with the new information provided by the cnor (stated above), a new review of the complaint was performed.According to the information received, there was no flame or sparks noted.When the light bulb assembly was removed, it was noted to have the burnt appearance.No one was injured when handling this and the issue was realized prior the patient was in the or.The risk is covered in the related risk file (sap-id: 300000166779; risk-id: 3.3.03; version: be; severity-level: 2 (due to software failure the fan does not work in a right way); probability-level: 1 (improbable)).Based on the risk analysis and the new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: D-LIGHT P HIGH POWER LIGHT UNIT FOR AF
• Common Device Name: LIGHT SOURCE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16573167
• Report Number: 9610617-2023-00062
• Device Sequence Number: 6127429
• Product Code: OWN
• UDI-Device Identifier: 04048551004685
• UDI-Public: 04048551004685
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152583
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 20133720-1
• Device Catalogue Number: 20133720-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 01/18/2023; 03/28/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 03/21/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown