MAUDE Adverse Event Report: KARL STORZ IMAGING, INC. STORZ ICG LIGHT SOURCE; LIGHT SOURCE SYSTEM, DIAGNOSTIC ENDOSCOPIC

Model Number 201337 20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn, Thermal (2530)

Event Date 06/25/2018

Event Type  Injury  

Event Description

Pt sustained 5mm skin burn from light cord that was connected to storz icg light source which automatically defaults to 100%.

• Brand Name: STORZ ICG LIGHT SOURCE
• Type of Device: LIGHT SOURCE SYSTEM, DIAGNOSTIC ENDOSCOPIC
• Manufacturer (Section D): KARL STORZ IMAGING, INC.
• MDR Report Key: 7826519
• MDR Text Key: 118744439
• Report Number: MW5079463
• Device Sequence Number: 1
• Product Code: OAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201337 20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR