ENDO-COAGULATOR 26027 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-12 for ENDO-COAGULATOR 26027 * manufactured by Karl Storz Endoscopy.

MAUDE Entry Details

• Report Number: 3305186
• MDR Report Key: 3305186
• Date Received: 2013-08-12
• Date of Report: 2013-08-12
• Date of Event: 2013-07-30
• Report Date: 2013-08-12
• Date Reported to FDA: 2013-08-12
• Date Reported to Mfgr: 2013-08-23
• Date Added to Maude: 2013-08-23
• 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: 0
• 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: ENDO-COAGULATOR
• Generic Name: ELECTRODE, FLEXIBLE SUCTION COAGULATOR
• Product Code: HIN
• Date Received: 2013-08-12
• Model Number: 26027
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KARL STORZ ENDOSCOPY
• Manufacturer Address: 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-08-12