MAUDE Adverse Event Report: CAREFUSION FIBER-OPTIC LIGHT CABLE 3.5MMX7.5FT A/A; LIGHT, SURGICAL, FIBEROPTIC

Model Number 88-9760

Device Problems Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): should additional information be received a follow-up emdr will submitted.

Event Description

Customer stated via email, on (b)(6) 2015 we had an incident where the retractor was set on the patient's skin and they were burned and developed a blister.An incident form was filled out but i am told by the staff that this type of situation is somewhat common with these retractors.Apparently where the light cord attaches to the retractor is the region that heats up and causes the burns.Additional information received 09 sep 2015: the customer reported no additional information.

• Brand Name: FIBER-OPTIC LIGHT CABLE 3.5MMX7.5FT A/A
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS; 5175 south royal atlanta dr; tucker 30084
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5093845
• MDR Text Key: 26678290
• Report Number: 1038548-2015-00071
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 88-9760
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1