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U.S. Department of Health and Human Services

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

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JOHNSON AND JOHNSON PROFESSIONAL, INC. AFI/AFI 5MMX10FT LO PROFL FIBEROPTIC ILLUMINATOR FOR ENDOSCOPE Back to Search Results
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.
 
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Brand NameAFI/AFI 5MMX10FT LO PROFL
Type of DeviceFIBEROPTIC 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 Key5568050
MDR Text Key42409850
Report Number1226348-2016-10289
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
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
Date FDA Received04/11/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number24-3074
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2016
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 Treatment Data
Date Received: 04/11/2016 Patient Sequence Number: 1
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