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

Model Number	20161420-1
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer will not return the device 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
It was reported that during a cystoscopy procedure on (b)(6) 2024, the surgical team asked for the equipment to be turned on in preparation for the cystoscopy.Right after the equipment was turned on, the scrub tech noticed a smoky smell and picked up the light cord.An inspection of the drapes revealed a burn hole.Drapes were then pulled back and patient's skin was inspected for any injury.Fortunately, no injury was observed by the surgeon or the staff.
Additional Manufacturer Narrative
Customer filed medwatch number mw5156852 to the fda from their end.Per investigation by the manufacturing site: the described event is clearly written in the ifu as a warning.For that reason, the most probable root cause is customers mishandling of the equipment which leads the drape to burn.This event is filed under internal complaint id (b)(4).

• Brand Name: POWER LED 175, W/O ACC.
• Common Device Name: POWER LED 175
• 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 ; 4242188247
• MDR Report Key: 19997563
• Report Number: 9610617-2024-00295
• Device Sequence Number: 7123355
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 04048551288900
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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
• Device Model Number: 20161420-1
• Device Catalogue Number: 20161420-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 47 YR
• Patient Sex: Female