MAUDE Adverse Event Report: KARL STORZ GMBH & CO.; LED LIGHT SOURCE

Lot Number 0002

Device Problem Overheating of Device (1437)

Patient Problem Blister (4537)

Event Date 03/30/2021

Event Type  malfunction  

Event Description

2 blisters secondary to light cord activation.Nursing, periop nursing, notified documented and protocol initiated.I spoke to the patient's husband and explained, showed images.His main concern was being upset that he heard a code red called over public address (pa) system in room and thought there was a fire.I reassured him.Code red was called after completion of surgery and 25 minutes after we identified injury.

Event Description

Two blisters secondary to light cord activation.Nursing, periop nursing, notified documented and protocol initiated.I spoke to the patient's husband and explained, showed images.His main concern was being upset that he heard a code red called over public address (pa) system in room and thought there was a fire.I reassured him.Code red was called after completion of surgery and 25 minutes after we identified injury.

• Type of Device: LED LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ GMBH & CO.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 11723690
• MDR Text Key: 247278140
• Report Number: 11723690
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25915 DA
• Patient Weight: 55