MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ LIGHT SOURCE; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number 201331-20

Device Problems Smoking (1585); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Event Description

During the procedure, the gu tower's light source stopped working and smoke was coming out of the tower as stated by scrub and physician.When this occurred, the circulator and additional scrub went out into the core to find items; both did not witness the event.Once the circulator returned there was the smell of smoke in the room and surgeon provided the stated information.Circulator assessed the patient and equipment; patient was safe.The urology lead was called into the room.The gu tower was unplugged and removed from the room.Equipment was initially plugged into electrical outlet panel-f1-cir6 and panel-f1-cir4 prior to issue.The lead brought into the room an ortho video tower (as general towers were unavailable for use).The lead also removed from the room the camera and light source attached to the urology tower to take for evaluation.Surgery continued at 1424 without any issues.At 1439, the monitors plugged into the outlet panel-f1-cir9 lost power which returned within a second.Surgery was successfully completed without further electrical issues.Patient was transferred to post-anesthesia care unit (pacu) without issues.

• Brand Name: KARL STORZ LIGHT SOURCE
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8503128
• MDR Text Key: 141582944
• Report Number: 8503128
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 201331-20
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Weight: 98