N
Patient 1
(B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
MAUDE MDR 5034843
- MDR report key
- 5034843
- Report number
- 1038548-2015-00069
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-04
- Date received
- 2015-08-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JILL RITTORNO
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TEBBETTS FIBEROPTIC SS RETR 15CMX30MM | RETRACTOR, FIBEROPTIC | CAREFUSION | FDG | UNK - V. MUELLER | UNKNOWN | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-27 | 0 |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED, CURRENTLY WE DO A NUMBER OF CASES THAT UTILIZE THE SNOWDEN PENCER LIGHTED BREAST RETRACTOR. YESTERDAY (B)(6) 2015 WE HAD AN INCIDENT WHERE THE RETRACTOR WAS SET ON THE PATIENTS SKIN AND THEY WERE BURNED AND DEVELOPED A BLISTER. AN INCIDENT FORM WAS FILLED OUT BUT I AM TOLD BY THE STAFF THAT THIS TYPE OF SITUATION IS SOMEWHAT COMMON WITH THESE RETRACTORS. APPARENTLY WHERE THE LIGHT CORD ATTACHES TO THE RETRACTOR IS THE REGION THAT HEATS UP AND CAUSES THE BURNS.
N
Patient 1
(B)(4): CAREFUSION WILL NOT BE RECEIVING THE INSTRUMENT FOR EVALUATION THE CUSTOMER REPORTED, THEY HAD AN INCIDENT WHERE THE RETRACTOR WAS SET ON THE PATIENT?S SKIN AND THEY WERE BURNED AND DEVELOPED A BLISTER. ACCORDING TO THE CUSTOMER THEY HAVE MULTIPLE LIGHTED BREAST RETRACTORS SO IT WOULD BE IMPOSSIBLE TO DETERMINE WHICH ONE IT WAS. THE 88-1088 TEBBETTS FIBEROPTIC SS RETRACTOR WAS NOT RECEIVED FOR EVALUATION BUT A PHOTO OF THE INSTRUMENT WAS PROVIDED. A LOT NUMBER OR DATE CODE WAS NOT PROVIDED; THEREFORE, A DHR REVIEW COULD NOT BE PERFORMED. PER EXAMINATION BY THE (B)(6) AND (B)(6) OF PROVIDED PHOTO THE DEVICE WAS CONFIRMED TO BE 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. ALTHOUGH THE DEVICE WAS NOT RECEIVED FOR EVALUATION THE REPORTED INCIDENT DEMONSTRATES MISUSE OF THE INSTRUMENT BY THE CUSTOMER. PER THE INSTRUCTIONS FOR USE (IFU) 26-0067 REV D, ?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 AND 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 RECOMMENDATION IS FOR THE CUSTOMER 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. CAREFUSION WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT CODE.
N
Patient 1
(B)(4): SHOULD ADDITIONAL INFORMATION BE RECEIVED A FOLLOW-UP EMDR WILL SUBMITTED.
D
Patient 1
ADDITIONAL INFORMATION RECEIVED 31AUG2015: THE CUSTOMER REPORTED THE RETRACTOR IS ITEM NUMBER 88-1088 AND THE LIGHTED CABLE IS 88-9760. ADDITIONAL INFORMATION RECEIVED 09SEP2015: THE CUSTOMER REPORTED NO ADDITIONAL INFORMATION.
N
Patient 1
(B)(4): A REPRESENTATIVE COMPLAINT SAMPLE WAS RECEIVED BY CAREFUSION. ACCORDING TO THE CUSTOMER THEY HAVE MULTIPLE LIGHTED BREAST RETRACTORS SO IT WOULD BE IMPOSSIBLE TO DETERMINE WHICH ONE IT WAS. IT WAS CONFIRMED BY THE LOT NUMBERS PROVIDED BY THE RETURNED DEVICES THAT THE 88-1088 AND 88-1086 TEBBETT RETRACTORS WERE BOTH FROM THE OLD DESIGN AND WERE MANUFACTURED IN 2009. IN THE CASE OF THIS COMPLAINT THE CUSTOMER DID USE THE CORRECT SIZE CABLE BUT WHILE IN USE LAID THE RETRACTOR ON A PATIENT?S SKIN. THIS REPORTED INCIDENT DEMONSTRATES MISUSE OF THE INSTRUMENT BY THE CUSTOMER. THIS REPORTED CUSTOMER MISUSE HAS BEEN PREVIOUSLY IDENTIFIED WITH THE LIGHTED TEBBETTS BREAST RETRACTOR FAMILY AND A PROJECT WAS 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. PER THE INSTRUCTIONS FOR USE (IFU) 26-0067 REV D, ?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. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. 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. CAREFUSION WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.