MAUDE Adverse Event Report: CAREFUSION 2200 SNOWDEN PENCER; LAPAROSCOPIC SCISSORS

Model Number 90-1053

Device Problem Break (1069)

Patient Problem Bowel Burn (1756)

Event Date 12/15/2016

Event Type  Injury  

Event Description

Insulation on hot metz was compromised in multiple places.Electricity arched to bowel and caused a burn that required dr to perform and colectomy with anastomosis.This item is a reprocessed item, not a single use item.

• Brand Name: SNOWDEN PENCER
• Type of Device: LAPAROSCOPIC SCISSORS
• Manufacturer (Section D): CAREFUSION 2200
• MDR Report Key: 6349234
• MDR Text Key: 68110573
• Report Number: MW5068011
• Device Sequence Number: 0
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Device Operator: Health Professional
• Device Model Number: 90-1053
• Device Catalogue Number: 90-1053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention