MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWER LED 175, W/O ACC.

Model Number	20161420-1
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: case no.(b)(4).
Event or Problem Description
It has been reported the staff has received burns from the light lead caused by this device.
Additional Manufacturer Narrative
During inspection at our repair facility a charred fiber taper was detected.This is assumed to be caused either by a dirty or unsuitable fiber optic cable.Due to the contamination or unsuitable light guide, the light cannot be guided sufficiently to the outside and the fiber taper heats up so much that it gets charred.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This supplemental report is to correct section d9 to reflect the correct device return date and section h6 conclusion code for the evaluation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: POWER LED 175, W/O ACC.
• Common Device Name: POWER LED
• 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: 16353971
• Report Number: 9610617-2023-00038
• Device Sequence Number: 12499421
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2023

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: 20161420-1
• Device Catalogue Number: 20161420-1
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 05/30/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/26/2023; 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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