MAUDE Adverse Event Report: CAREFUSION 2200, INC SNOWDEN-PENCER DIAMOND VIEW RETRACTOR SYSTEM; RETRACTOR, FIBEROPTIC

Model Number 88-1001

Device Problem No Device Output (1435)

Patient Problem Burn, Thermal (2530)

Event Date 11/13/2019

Event Type  malfunction  

Event Description

Patient was undergoing a breast implant expander surgery/breast reconstruction, left and right with revision of axillary scar-1 1/2 hr procedure, with lighted retractors.Fiber optic retractors used with a fiber optic light system.The fiber optic cable connector (which attaches the retractor to the power source))heated up and transmitted heat to the patient resulting in a burn.

• Brand Name: SNOWDEN-PENCER DIAMOND VIEW RETRACTOR SYSTEM
• Type of Device: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION 2200, INC; 5 sunnen dr; saint louis MO 63143
• MDR Report Key: 9686477
• MDR Text Key: 178335558
• Report Number: 9686477
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88-1001
• Device Catalogue Number: 88-1001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16790 DA