N
Patient 1
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
MAUDE MDR 5042121
- MDR report key
- 5042121
- Report number
- 1820334-2015-00522
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-08-05
- Date received
- 2015-08-31
- 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
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-31 | 0 | 1. O |
Event Narratives#
D
Patient 1
DURING A COLON PROCEDURE, OVERHEATING OCCURRED AT THE JUNCTION WHERE THE CATHETER PLUGS INTO THE BLACK CORD. ACCORDING TO THE REPORTER, THE LOCATION OF THE JUNCTION IS WHERE THE DEVICE MELTED, RESULTING IN BURNING THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 06AUG2015: IT WAS NOTED THAT THE CATHETER WAS DRAPED OVER THE "BOVIE PAD" AND THIS IS WHERE THE LIGHTED PORTION OF THE CATHETER MELTED APART FROM THE BLACK HOUSING.
N
Patient 1
(B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND MANUFACTURING INSTRUCTIONS WAS CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMS THAT THE CABLE MELTED AT THE CONNECTOR AND PULLED APART. THE IFU INSTRUCTS TO, ?START ILLUMINATION WITH THE LIGHT SOURCE AT THE LOWEST SETTING, AS MANY LIGHT SOURCES PRODUCE THERMAL ENERGY AT VARYING TEMPERATURES. THIS WILL LIMIT THE POSSIBILITY OF THERMAL DAMAGE AT THE CATHETER LIGHT PLUG JUNCTIONS. IT IS INADVISABLE TO USE ANY LIGHT SOURCE AT ITS HIGHEST SETTING, UNLESS THE LIGHT SOURCE?S ACTUAL THERMAL ENERGY OUTPUT IS KNOWN.? ?THIS CATHETER WILL NOT TRANSMIT THERMAL ENERGY ALONG ITS LIGHT FIBERS TO PATIENT TISSUE. ANY EXCESSIVE THERMAL DAMAGE FROM THE LIGHT SOURCE WILL MANIFEST AT THE CATHETER/LIGHT PLUG JUNCTION AND WILL NOT BE TRANSMITTED ALONG THE CATHETER LENGTH.? THE BUSH SINGLE LUMEN URETERAL ILLUMINATING CATHETER FUNCTIONED AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE EVIDENCE DISPLAYED INDICATES THE DEVICE HAS BEEN EXPOSED TO HIGH ENERGY FOR TOO LONG. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MADE TO SPECIFICATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.
D
Patient 1
DURING A COLON PROCEDURE, OVERHEATING OCCURRED AT THE JUNCTION WHERE THE CATHETER PLUGS INTO THE BLACK CORD. ACCORDING TO THE REPORTER, THE LOCATION OF THE JUNCTION IS WHERE THE DEVICE MELTED, RESULTING IN BURNING THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 06AUG2015: IT WAS NOTED THAT THE CATHETER WAS DRAPED OVER THE "BOVIE PAD" AND THIS IS WHERE THE LIGHTED PORTION OF THE CATHETER MELTED APART FROM THE BLACK HOUSING.
N
Patient 1
ADVERSE EVENT AND/OR PRODUCT PROBLEM, DESCRIBE EVENT OR PROBLEM, CONCOMITANT MEDICAL PRODUCTS, PMA# - ADDITIONAL INFORMATION, CLARIFICATION OF EVENT DETAILS. CONCOMITANT MEDICAL PRODUCTS - LIGHT SOURCE: LUXTEC - MANUFACTURER - INTERGA. CONCOMITANT MEDICAL PRODUCTS - "BOVIE PAD" - ELECTROCAUTERY RF GROUNDING PAD - UNSPECIFIED.
D
Patient 1
DURING A COLON PROCEDURE, OVERHEATING OCCURRED AT THE JUNCTION WHERE THE CATHETER PLUGS INTO THE BLACK CORD. ACCORDING TO THE REPORTER, THE LOCATION OF THE JUNCTION IS WHERE THE DEVICE MELTED, RESULTING IN BURNING THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 06AUG2015: IT WAS NOTED THAT THE CATHETER WAS DRAPED OVER THE "BOVIE PAD" AND THIS IS WHERE THE LIGHTED PORTION OF THE CATHETER MELTED APART FROM THE BLACK HOUSING. THE REPORT INDICATES THAT THE PATIENT SUFFERED A MINOR BURN THAT DID NOT REQUIRE INTERVENTION. THE DEVICE WAS IN USE FOR APPROXIMATELY THREE (3) HOURS BEFORE THE OVERHEATING WAS OBSERVED. THE LIGHT SOURCE WAS AN INTEGRA-LUXTEC AND WAS SET TO 100% CAPACITY FOR THE DURATION OF USE. ADDITIONAL INFORMATION WAS REQUESTED; NO INFORMATION HAS BEEN RECEIVED TO DATE. THE INSTRUCTIONS FOR USE THAT ACCOMPANY EACH DEVICE STATES UNDER THE PRECAUTIONS SECTION THAT" THE ANODIZED ALUMINUM PLUG CONDUCTS HEAT. ALLOW THE PLUG TO COOL DOWN PRIOR TO ATTEMPTING TO UNPLUG." THE INSTRUCTIONS FOR USE ALSO STATE UNDER THE INSTRUCTIONS FOR USE SECTION THAT: " NOTE: THIS CATHETER WILL NOT TRANSMIT THERMAL ENERGY ALONG ITS LIGHT FIBERS TO PATIENT TISSUE. ANY EXCESSIVE THERMAL DAMAGE FROM THE LIGHT SOURCE WILL MANIFEST AT THE CATHETER/LIGHT PLUG JUNCTION AND WILL NOT BE TRANSMITTED ALONG THE CATHETER LENGTH." "NOTE: HIGH-ENERGY LIGHT SOURCES SUCH AS XENON MAY CAUSE OVERHEATING OF THE ANODIZED ALUMINUM PLUG. AN ADAPTER (AVAILABLE FROM MOST LIGHT SOURCE MANUFACTURERS) WILL ENSURE PRODUCT SAFETY AND FUNCTIONALITY." "NOTE: START ILLUMINATION WITH THE LIGHT SOURCE AT THE LOWEST SETTING, AS MANY LIGHT SOURCES PRODUCE THERMAL ENERGY AT VARYING TEMPERATURES. THIS WILL LIMIT THE POSSIBILITY OF THERMAL DAMAGE AT THE CATHETER/LIGHT PLUG JUNCTION."