MAUDE Adverse Event Report: JOHNSON AND JOHNSON PROFESSIONAL, INC. AFI/AFI 5MMX10FT LO PROFL; FIBEROPTIC ILLUMINATOR FOR ENDOSCOPE

Catalog Number 24-3074

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

Udi: lot number unknown; gtin unavailable, product made prior to compliance date.Upon completion of the investigation, a follow up report will be filed.

Event Description

Patient underwent extensive revision at site of prior right breast reconstruction and repair of 2 ventral hernias.A lighted retractor, used to illuminate the surgical site, was placed on patient's abdomen when not in use.It was reported that the handle of the fiber optic cable was emitting heat when off, and that it caused a thermal injury.

Manufacturer Narrative

The customer was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.Device not available.

• Brand Name: AFI/AFI 5MMX10FT LO PROFL
• Type of Device: FIBEROPTIC ILLUMINATOR FOR ENDOSCOPE
• Manufacturer (Section D): JOHNSON AND JOHNSON PROFESSIONAL, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5568050
• MDR Text Key: 42409850
• Report Number: 1226348-2016-10289
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 24-3074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR