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 Bradycardia (1751)

Event Date 01/01/2023

Event Type  Injury  

Event Description

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

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: (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
• MDR Report Key: 16354004
• MDR Text Key: 309299314
• Report Number: 2020550-2023-00038
• Device Sequence Number: 1
• Product Code: NTN
• UDI-Device Identifier: 04048551288900
• UDI-Public: 4048551288900
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2023,02/10/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other