MAUDE Adverse Event Report: CAREFUSION TEBBETTS FIBEROPTIC SS RETR 15CMX30MM; RETRACTOR, FIBEROPTIC

Model Number 88-1188

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/17/2014

Event Type  Injury  

Event Description

Patient was burnt by fiberoptic cord/handle connector: additional information received from the customer 22oct2014.It was reported that during a bilateral mastectomy with reconstruction (4-41/2 hrs), the patient was burned on the left lateral breast along the incision line.  the patient had a 2nd degree burn in several spots along the incision line.The most affected area on the lateral breast.Most of the burn was excised. bactroban was placed on the wound as well as a telfa dressing.During the procedure, the retractor was not wrapped in a wet lap.Per the customer, the instrument was placed on the patient without a barrier.The light source is shut off if not used for prolonged periods of time but will be left on if only put down for a few minutes.The procedure was completed as planned.: additional information received from the sales rep 27oct2014.It was reported that the sales rep went to visit the customer 17oct2014.The sales rep discussed carefusion's ifu (instructions for use) for the tebbetts retractor and gave them a copy.It is unknown whether the instrument will be received for evaluation at this time.

Manufacturer Narrative

(b)(4).Should the device become available, a follow-up emdr will be submitted.

Manufacturer Narrative

The customer did not return product for evaluation the clinicians were using the retractors improperly and not following the directions found in the ifu resulting in areas of the device becoming hot enough to cause minor burns.The current device design is such that the use of improperly sized light cables, improper cleaning, overuse of the light source and other factors may cause the device to become hot.Review of root causes from previous complaints and capa (b)(4) investigation further confirms this root cause as investigations have historically revealed that user error was the root cause of all the incidents in which the customer provided information or a returned sample was available for evaluation.(b)(4).The products information, ifu 26-0067-d states: ¿this device transmits high energy light.The metal connectors of the fiber optic bundle and the exposed tip may become hot during use.Never lay the device on a patient or on patient drapes¿.An in-service has already occurred at the customer by the sales rep on 17oct14.The sales rep discussed carefusion's ifu (instructions for use), 26-0067 rev d for the tebbetts retractor and gave them a copy.

• Brand Name: TEBBETTS FIBEROPTIC SS RETR 15CMX30MM
• Type of Device: RETRACTOR, 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: 4239707
• MDR Text Key: 21724033
• Report Number: 1038548-2014-00049
• Device Sequence Number: 1
• Product Code: FDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 88-1188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other