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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-19 for * manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[4104104] Following administration of adequate general endotracheal anesthesia, a veress needle was inserted into the left upper quadrant. The abdomen was then insufflated with approximately 4 l of carbon dioxide. Next, an 11 mm vertical incision was made and a 11 mm trocar and portal were inserted. The trocar was removed and the port was connected to the insufflator. A storz light source and video camera were connected to a 10 mm angled diagnostic laparoscope. This was inserted into the umbilical port. The veress needle was visualized and removed. Next, accessory portals were placed in the upper abdomen. At this point, we began with lysis of the adhesions. Smoke was noted to be coming from the storz light source. The procedure was immediately terminated. Storz light source and insufflator were disconnected from the patient. All ports were removed. Carbon dioxide was allowed to escape. Instruments and ports removed and fire rapidly controlled. Once the fire involving the storz light source had been controlled and the patient was stabilized, the patient was moved to a different operating room with other equipment. The procedure was completed without further incidence, and no untoward effects to patient. The patient taken to recovery in stable condition.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3537486
• MDR Report Key: 3537486
• Date Received: 2013-12-19
• Date of Report: 2013-12-19
• Date of Event: 2013-10-28
• Report Date: 2013-12-19
• Date Reported to FDA: 2013-12-19
• Date Reported to Mfgr: 2013-12-26
• Date Added to Maude: 2013-12-26
• 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
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: LIGHT SOURCE, CAMERA
• Product Code: FCR
• Date Received: 2013-12-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-12-19