MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LIGHTED RETRACTOR; LUXTEC

Catalog Number 001459

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Burn(s) (1757)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer reports that the retractor got very hot at the light cord connection and burned the patient.The retractor is being sequestered and our clinical engineering department could not duplicate the event.On (b)(6) 2017 customer reports a ¿bilateral breast insertion of tissue expanders" was being performed.On (b)(6) 2017 customer reports only one blister 1cm x 3cm, 2nd degree.Treated with "local care" and healed well.

Manufacturer Narrative

On 2/9/2017 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed/no return of device for evaluation.Device history evaluation - dhr cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Conclusion- root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

• Brand Name: LIGHTED RETRACTOR
• Type of Device: LUXTEC
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6291476
• MDR Text Key: 66222368
• Report Number: 2523190-2017-00010
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 001459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR