MAUDE Adverse Event Report: NUVASIVE, INC. MAXCESS LIGHT CABLE GUIDE; LIGHT, SURGICAL, FIBEROPTIC

Model Number 3400044

Device Problem Detachment Of Device Component (1104)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 06/12/2014

Event Type  Other  

Event Description

It was reported that during a plif spinal surgery, the sterile light cable fell out of the retractor and out of the surgical site, and came in contact with the drape and the patient's skin.The duration of the accidental disconnection from the retractor is unknown.When noticed, the light cable was removed from the patient and a dime size (or smaller) vesication was evident.The minor injury was noted to have redness, swelling and small blistering that was treated with silvadene ointment at the time of the event.No additional treatment or intervention was reported.

Manufacturer Narrative

(b)(4).Photo confirmed the reported event.After the patient was treated with silvadene ointment and there has been no report of infection or deterioration of the patient's health.There was no alleged malfunction of the disposable light cable and the light cable was inadvertently discarded by hospital due to its single use nature.It is unknown how the light cable disconnected from the retractor.The device was not returned and could not be investigated further.No other events of this nature have been reported in the last four years.The cause of the issue was the accidental disconnection of the light cable from its intended retractor attachment position.This is an isolated incident.The heat generated from the light cable is a known characteristic of fiber optic light cables and care should be taken to ensure proper placement in the surgical site and retention within the retractor.

• Brand Name: MAXCESS LIGHT CABLE GUIDE
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd.; san diego, CA 92121 ; 8589093347
• MDR Report Key: 3982613
• MDR Text Key: 4819623
• Report Number: 2031966-2014-00047
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: 3400044
• Device Lot Number: LS0261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/12/2014
• Event Location: Hospital
• Date Manufacturer Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1