POWERLED
Report
- Report Number
- 9710055-2018-00024
- Event Type
- Injury
- Date Received
- April 30, 2018
- Date of Event
- April 6, 2018
- Report Date
- July 9, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE SURGICAL LIGHT IS UNDER MAQUET SAS PREVENTIVE MAINTENANCE PROGRAMME. THE SKIN BURN WAS NOTICED AT THE END OF THE PROCEDURE. THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS INVESTIGATED BY MANUFACTURING SITE.
(B)(4). EXEMPTION # E2018005. (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED, THE PATIENT SUSTAINED A SKIN BURN AFTER A SURGICAL PROCEDURE. FROM THE INFORMATION RECEIVED SO FAR, THERE WERE NO OTHER CONSEQUENCES REPORTED IN RELATION TO PATIENT STATE. THERE WAS NO MEDICAL TREATMENT APPLIED ON THE IRRITATED AREA. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT MET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THIS COMPLAINT IS CONSIDERED AS SINGLE, ISOLATED EVENT. MANUFACTURING SITE TRIED TO OBTAIN MORE INFORMATION REGARDING THE SKIN PHOTOTYPE, PHOTO OF INFLAMED AREA, THE LEVEL OF ILLUMINATION, THE USE OF ELECTROSURGICAL UNIT, THE LENGTH OF TIME FOR PROCEDURE, THE ILLUMINANCE AND VOLTAGE, HOWEVER NO ADDITIONAL INFORMATION WERE PROVIDED. BURN CAN BE CAUSED BY A VARIETY OF EXTERNAL SOURCES CLASSIFIED AS THERMAL, CHEMICAL, ELECTRICAL AND RADIATION. DURING A SURGERY, MANY FACTORS CAN CONTRIBUTE TO A SKIN INFLAMMATION AS PHOTOSENSITIVITY REACTION CORRESPONDING TO THE TAKING OF PHOTOTOXIC OR PHOTOALLERGIC SUBSTANCE, THE PATIENT PHOTOSENSITIVITY AND AS THE CONCOMITANT USE OF ELECTROSURGICAL UNIT AND ANTISEPTIC ALCOHOL. MAQUET HAS BEEN INFORMED THAT PATIENT INVOLVED IN THIS INCIDENT WAS A (B)(6) MONTHS OLD BABY. DURING THE FIRST YEAR OF LIFE, THE BABY¿S SKIN IS MORE VULNERABLE. GETTING TOO MUCH LIGHT IS ESPECIALLY DANGEROUS FOR BABIES, WHOSE SENSITIVE SKIN HASN¿T DEVELOPED ENOUGH LAYERS OF NATURAL PROTECTION TO PROLONGED EXPOSURE. PROLONGED EXPOSURE COMBINED WITH THE OVERLAPPING OF 3 LIGHT PATCHES CAN CONTRIBUTE TO THE INFLAMMATION OF THE SKIN, IT IS POSSIBLE THAT PATIENTS WITH PHOTO SENSITIVE SKIN WOULD SUSTAIN A SKIN BURN. IT IS WORTH NOTING THAT POWERLED USER MANUAL INCLUDES A WARNING TO SET THE APPROPRIATE ILLUMINATION LEVELS FOR EACH OPERATION AND PATIENTS TO PREVENT ANY ADVERSE OUTCOME FROM OCCURRING. BASED ON THE PERFORMED INVESTIGATION AND WITH THE LIMITED INFORMATION RECEIVED WE WERE NOT ABLE TO CONCLUDE AN ACTUAL ROOT CAUSE THAT HAS LED TO THE EVENT OCCURRENCE. WE DID HOWEVER CONFIRM THAT INVOLVED DEVICE WAS WORKING CORRECTLY AND NO MALFUNCTION WAS FOUND WITH THE UNIT. IT SEEMS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE COMBINATION OF PATIENT¿S INDIVIDUAL ASPECTS AND THE TYPE OF SURGICAL PROCEDURE THAT WAS USED WITH THE PATIENT. WE BELIEVE THAT THIS TYPE OF OUR DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
(B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERED. AS IT WAS STATED, AFTER PROCEDURE THE SKIN BURN OCCURRED ON THE PATIENT. THERE ARE NO OTHER CONSEQUENCES TO THE PATIENT. MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316414 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |