SCULPO BREAST RETRACTOR

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO US. NO ISSUES INVOLVING THIS DEVICE HAVE BEEN RECORDED IN THE PAST. NO ADDITIONAL INVESTIGATION IS POSSIBLE SINCE DEVICE WAS NOT RETURNED TO US AND NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING FROM OUR DISTRIBUTOR OR FROM USER FACILITY. WE CAN NOT RATE THE USE OF COMBINATION PRODUCTS SINCE WE RECEIVED ANY INFORMATION. THE BREAST RETRACTOR DOES NOT CONDUCT NOR EMIT HEAT EVEN WHEN CONNECTED TO AN ACTIVE LIGHT SOURCE, THUS ALLOWING OR PERSONNEL TO HOLD AND SAFELY MANIPULATE THE INSTRUMENT DURING SURGICAL PROCEDURES. HOWEVER, THE LIGHT SOURCE DOES GENERATE HEAT AND CAN CAUSE THE ADAPTER CONNECTION TO HEAT UP SUFFICIENTLY TO CAUSE BURNS. A WARNING STATEMENT TO THIS EFFECT IS CONSPICUOUSLY FEATURED WITH THE IFU. IN ADDITION, ROUTINE HOSPITAL PROTOCOL DICTATES NEVER TO PLACE AN INSTRUMENT ON PATIENT.

Description of Event or Problem

DURING SURGERY FOR MASTECTOMY WITH RECONSTRUCTION, THE ASSEMBLED BREAST RETRACTOR, ADAPTER, AND LIGHT CORD WERE PLACED ON THE PATIENT'S ABDOMEN BY OUR PERSONNEL. THE LIGHT CORD WS CONNECTED TO AN ACTIVE LIGHT SOURCE AT THE TIME . THE PATIENT SUFFERED A SUPERFICIAL PARTIAL THICKNESS BURN ON LEFT UPPER ABDOMEN.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO US. NO ISSUES INVOLVING THIS DEVICE HAVE BEEN RECORDED IN THE PAST. NO ADDITIONAL INVESTIGATION IS POSSIBLE SINCE DEVICE WAS NOT RETURNED TO US AND NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING FROM OUR DISTRIBUTOR OR FROM USER FACILITY. WE CAN NOT RATE THE USE OF COMBINATION PRODUCTS SINCE WE RECEIVED ANY INFORMATION. THE BREAST RETRACTOR DOES NOT CONDUCT NOR EMIT HEAT EVEN WHEN CONNECTED TO AN ACTIVE LIGHT SOURCE, THUS ALLOWING OR PERSONNEL TO HOLD AND SAFELY MANIPULATE THE INSTRUMENT DURING SURGICAL PROCEDURES. HOWEVER, THE LIGHT SOURCE DOES GENERATE HEAT AND CAN CAUSE THE ADAPTER CONNECTION TO HEAT UP SUFFICIENTLY TO CAUSE BURNS. A WARNING STATEMENT TO THIS EFFECT IS CONSPICUOUSLY FESTURED ITH THE IFU. IN ADDITION, ROUTINE HOSPITAL PROTOCOL DICTATES NEVER TO PLACE AN INSTRUMENT ON PATIENT. FOLLOW-UP REPORT DATED: WE GOT DATA FROM OUR CUSTOMER/DISTRIBUTOR: ON MAY 27, 2016 WE CONTACTED (B)(6) AT (B)(6) AFTER RECEIVING BY MAIL ON MAY 27, 2016 FROM THE FDA A LETTER AND REPORT (MW5055905) DATED 03-SEP-2015, OVER 8 MONTHS AFTER THE EVENT. THE REPORT WAS FOR AN EVENT AT (B)(6) REGARDING THE ABOVE BREAST RETRACTOR WHERE THE PATIENT SUFFERED AN INJURY. NOTE: MAY 27, 2016 WAS THE FIRST WE HEARD OF OR WERE ADVISED OF THE EVENT. THE HOSPITAL NEVER ADVISED US OF THE EVENT WHEN IT OCCURRED. AT NO TIME DID THE HOSPITAL CONTACT (B)(4) AT THE TIME OF THE EVENT. WE CALL (B)(6) ON MAY 27, 2016 AND AGAIN ON MAY 31, 2016 RECEIVING NO RESPONSE TO OUR INITIAL PHONE CALL. (B)(6) RETURNED OUR PHONE CALL MAY 31, 2016. SHE PROVIDED DETAILS OF THE EVENT STATING THAT ONE OF THE STAFF IN THE OR PLACED/LAID DOWN THE BREAST RETRACTOR ON PATIENT CAUSING AN INJURY TO THE PATIENT. SHE WAS ADVISED THAT THE BREAST RETRACTOR DOES NOT CONDUCT HEAT AND THAT IS WHY THE SURGEON OR ASSISTANT IS ABLE TO HOLD THE HANDLE OF THE RETRACTOR DURING THE PROCEDURE. WE REQUESTED THAT THE RETRACTOR BE RETURNED TO (B)(4) FOR EVALUATION, HOWEVER, SHE STATED IT WAS NOT POSSIBLE. WE REMINDED MS. (B)(6) OF THE WARNING ON THE IFU (VALIDATED BY RZ) REGARDING HIGH PERFORMANCE LIGHT SOURCES, LIGHT CABLE AND CONNECTION AT THE BREAST RETRACTOR CONNECTION AND REQUESTED THE NAME OF THE MANUFACTURE OF THE LIGHT CORD AND CONNECTOR. SHE WOULD NOT PROVIDE THAT INFORMATION. WE REQUESTED THE LOT NUMBER OF THE RETRACTOR AND OR THEIR PURCHASE ORDER NUMBER. WE ALSO REQUESTED THE NAME OF THE SURGEON AND INFORMATION REGARDING THE PATIENT'S CONDITION. WE CALLED AGAIN ON JUNE 1, 2016 AND LEFT A MESSAGE REQUESTING THE NECESSARY INFORMATION IN ORDER TO PREPARE OUR MDR. JUNE 1, 2016, (B)(6) CALLED AND LEFT A MESSAGE THAT THE LOT NUMBER WAS INCLUDED ON THE MEDWATCH REPORT. JUNE 1, 2016, WE RETURNED (B)(6) CALL AND ADVISED THAT THE LOT NUMBER WAS NOT INCLUDED ON THE MEDWATCH REPORT AND TO PLEASE PROVIDE THE PREVIOUSLY REQUESTED INFORMATION. HAVING HEARD NOTHING FROM (B)(6) , WE CALLED AGAIN ON JUNE 7, 2016 AND LEFT ANOTHER MESSAGE. WE CALLED AGAIN ON THE FOLLOWING DATES TO WHICH OUR MESSAGES AND INQUIRIES WERE IGNORED. JUNE 8, JUNE 9, JUNE 10, JUNE 13. NOTE THIS EVENT OCCURRED BECAUSE THE OR STAFF DID NOT HEED THE WARNING ON THE IFU VALIDATED BY RZ. DID NOT FOLLOW STANDARD METHODS FOR USING LIGHTED BREAST RETRACTORS AS TAUGHT IN ALL NURSING SCHOOLS DID NOT FOLLOW STANDARD PROTOCOLS FOR USE. NOTE WE HAVE RECEIVED NO OTHER COMPLAINTS FOR THE ABOVE BREAST RETRACTOR.

Description of Event or Problem

DURING SURGERY FOR MASTECTOMY WITH RECONSTRUCTION, THE ASSEMBLED BREAST RETRACTOR, ADAPTER, AND LIGHT CORD WERE PLACED ON THE PATIENT'S ABDOMEN BY OR PERSONNEL. THE LIGHT CORD WS CONNECTED TO AN ACTIVE LIGHT SOURCE AT THE TIME . THE PATIENT SUFFERED A SUPERFICIAL PARTIAL THICKNESS BURN ON LEFT UPPER ABDOMEN.