KARL STORZ LIGHT SOURCE 201331-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-11 for KARL STORZ LIGHT SOURCE 201331-20 manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[141582944] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8503128
• MDR Report Key: 8503128
• Date Received: 2019-04-11
• Date of Report: 2019-04-04
• Date of Event: 2019-03-14
• Report Date: 2019-04-04
• Date Reported to FDA: 2019-04-04
• Date Reported to Mfgr: 2019-04-11
• Date Added to Maude: 2019-04-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: KARL STORZ LIGHT SOURCE
• Generic Name: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Product Code: GCT
• Date Received: 2019-04-11
• Model Number: 201331-20
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-11