ENCISION ES-3512B *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-11 for ENCISION ES-3512B * manufactured by Encision, Inc..

Event Text Entries

[16616468] A pt had an initial laparotomy cholecystectomy procedure in 2004 and was discharged the next day. The pt returned to the emergency department with complaints of abdominal pain and the pt was medicated. Exploratory laparotomy was performed which did not identify source of pt's abdominal pain. The pt was presented to another facility in the system several days later with complaints of pain. Surgery revealed a bile duct injury right hepatic duct that appeared to be cautery injury, causing bile to collect in the abdomen. The injury was a circular area that appeared to be a burn. No further details are available on the burn. It was determined that the puller and the grasper are used interchangably in the procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 528484
• MDR Report Key: 528484
• Date Received: 2004-05-11
• Date of Report: 2004-03-01
• Date of Event: 2004-01-01
• Date Added to Maude: 2004-06-08
• 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ENCISION
• Generic Name: HOOK
• Product Code: FHB
• Date Received: 2004-05-11
• Model Number: ES-3512B
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 517675
• Manufacturer: ENCISION, INC.
• Manufacturer Address: 4828 STERLING DR BOULDER CO 80301 US

Device Sequence Number: 2

• Brand Name: ELECTROSHIELD ELECTROSCOPE
• Generic Name: HANDPIECE WITH PULLER
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: ES57005
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 518752
• Manufacturer: CONMED ELECTROSURGERY
• Manufacturer Address: 7211 SOUTH EAGLE ST CENTENNIAL CO 80112 US

Device Sequence Number: 3

• Brand Name: SPLASHRPOOF ELECTROSURGICAL FOOTSWITCH
• Generic Name: FOOT PEDAL
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: *
• Catalog Number: 60-5104-001
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 518756
• Manufacturer: CONMED ELECTROSURGERY
• Manufacturer Address: 7211 SOUTH EAGLE ST. CENTENNIAL CO 80112 US

Device Sequence Number: 4

• Brand Name: *
• Generic Name: AEM MONITOR - BIPOLAR GENERATOR
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: EM2TA
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 518757
• Manufacturer: ENCISION, INC.
• Manufacturer Address: 4828 STERLING DRIVE BOULDER CO 803012350 US

Device Sequence Number: 5

• Brand Name: EXCALIBUR
• Generic Name: ELECTROSURGICAL DEVICE
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: 60-5200-001
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 518758
• Manufacturer: CONMED ELECTROSURGERY
• Manufacturer Address: 7211 SOUTH EAGLE ST. CENTENNIAL CO 80112 US

Device Sequence Number: 6

• Brand Name: ENCISION
• Generic Name: ELECTRIC CORD
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: ES4007
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 520500
• Manufacturer: CONMED ELECTROSURGERY
• Manufacturer Address: 7211 SOUTH EAGLE ST. CENTENNIAL CO 80112 US
• Baseline Brand Name: AEM CORD
• Baseline Generic Name: AEM CORD
• Baseline Model No: ES4007
• Baseline Catalog No: ES4007
• Baseline ID: AEM LAPAROSCOPI
• Baseline Device Family: AEM LAPAROSCOPIC INSTRUMENT SYSTEM
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K913625
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 7

• Brand Name: ELECTROSHIELD ELECTROSCOPE
• Generic Name: HANDPIECE WITH SCISSORS
• Product Code: GEI
• Date Received: 2004-05-11
• Model Number: ES-57005
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 7
• Device Event Key: 520501
• Manufacturer: CONMED ELECTROSURGERY
• Manufacturer Address: 7211 SOUTH EAGE ST. CENTENNIAL CO 80112 US

Device Sequence Number: 8

• Brand Name: *
• Generic Name: SCISSOR INSERT
• Product Code: FHB
• Date Received: 2004-05-11
• Model Number: ES-0001
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 8
• Device Event Key: 520502
• Manufacturer: ENCISION, INC.
• Manufacturer Address: 4828 STERILING DR BOULDER CO 80301 US

Device Sequence Number: 9

• Brand Name: *
• Generic Name: TAPPERED MARYLAND DISSECTOR
• Product Code: FHB
• Date Received: 2004-05-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 9
• Device Event Key: 520504
• Manufacturer: ENCISION, INC.
• Manufacturer Address: 4828 STERLING DRIVE BOULDER CO 80301 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-05-11