FDA.reportPublic FDA data

MAUDE MDR 5573862

MDR report key
5573862
Report number
1038548-2016-00079
Event key
0
Event type
3
Date of event
2016-02-03
Date received
2016-04-13
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANNA WEHRHEIM
Address
75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US
Phone
847-847-8473
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TEBBETTS FIBEROPTIC SS RETR 15CMX30MMRETRACTOR, FIBEROPTICCAREFUSION, INCFDG88-1188N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-1301. O

Event Narratives#

N

Patient 1

(B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

D

Patient 1

REGULATORY REPORT FROM THE CUSTOMER RECEIVED STATED, A 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. PATIENT IS A WHITE, (B)(6) FEMALE. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION; NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

N

Patient 1

(B)(4): THE 88-1188 TEBBETTS FIBEROPTIC SS RETRACTOR WAS NOT RECEIVED FOR EVALUATION NOR WAS A PHOTO OF THE INSTRUMENT PROVIDED. A LOT NUMBER OR DATE CODE WAS ALSO NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. PER INFORMATION PROVIDED IT IS MOST PROBABLE THAT THE DEVICE WAS OF THE OLD DESIGN RETRACTOR THAT WOULD HEAT UP AND CAUSE BURNS IF THE DEVICE WAS UTILIZED WITH AN INCORRECT SIZE LIGHT CORD OR WAS LAID ON A PATIENT?S SKIN. IT IS UNKNOWN AS TO WHAT SIZE LIGHT CABLE WAS UTILIZED WITH THE BREAST RETRACTOR WHEN THE INCIDENT OCCURRED. THE PRODUCTS INFORMATION, IFU 26-0067 REV D STATES IN THE WARNING SECTION: ?THESE DEVICES MUST ONLY BE USED WITH A 3.5MM SIZE FIBER OPTIC BUNDLE CABLE. DO NOT USE THIS DEVICE WITH A LARGER SIZE CABLE. FAILURE TO USE THE CORRECTLY SIZED CABLE WILL CAUSE THE METAL CONNECTORS OF THE DEVICE / CABLE TO BECOME HOT DURING USE AND INCREASES THE POTENTIAL OF A THERMAL BURN. 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.? THE CUSTOMER DID NOT FOLLOW THE IFU WHICH CONTRIBUTED TO FAILURE AND PATIENT INJURY. THE ROOT CAUSE WAS MISUSE OF THE DEVICE BY THE CUSTOMER. THIS REPORTED CUSTOMER MISUSE HAS BEEN PREVIOUSLY IDENTIFIED WITH THE LIGHTED TEBBETTS BREAST RETRACTOR FAMILY PROJECTS WERE COMPLETED TO ADDRESS COMPLAINTS ASSOCIATED WITH THE LIGHTED TEBBETTS BREAST RETRACTOR FAMILY RELATED TO PATIENT BURNS AND AN IMPROVED DESIGN HAS BEEN IMPLEMENTED TO PREVENT USER ERROR. THE NEW DESIGN IS CURRENTLY BEING DISTRIBUTED FOR SALE. IT HAS BEEN RECOMMENDED TO REVIEW THE PRODUCTS INFORMATION, IFU 26-0067 REV D WHICH WAS INCLUDED WITH THE PACKAGING OF THE OLD DESIGN OF THIS DEVICE IN PARTICULAR THE WARNING, CAUTION AND PROCESSING SECTIONS FOR PROPER USE, HANDLING AND CARE. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.