MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY AMERICA KARL STOVE LIGHT SOURCE

Model Number 20133120

Device Problems Loose or Intermittent Connection (1371); Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

Capacitor for the light source became loose causing the device to overheat and smoke.This device was immediately taken out of service and removed from the operating room.No pt or staff harm was caused as a result.This pt was in surgery.He was intubated and in the process of having veins harvested for a cabg.

• Brand Name: KARL STOVE LIGHT SOURCE
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY AMERICA; el segundo CA 90245
• MDR Report Key: 3759625
• MDR Text Key: 4552626
• Report Number: MW5035679
• Device Sequence Number: 1
• Product Code: FFS
• 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: 04/14/2014

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 Operator: Health Professional
• Device Model Number: 20133120
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR