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

Model Number 20161420-1

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/01/2023

Event Type  Injury  

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 Description

It has been reported the staff has received burns from the light lead caused by this device.

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).

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.
• Type of Device: 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
• MDR Text Key: 309299022
• Report Number: 9610617-2023-00038
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other