POWERLED
Report
- Report Number
- 9710055-2018-00132
- Event Type
- Injury
- Date Received
- October 29, 2018
- Date of Event
- October 18, 2018
- Report Date
- January 10, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE ISSUE IS 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).
MAQUET SAS BECAME AWARE OF AN INCIDENT WITH POWERLED SURGICAL LIGHT. AS IT WAS INITIALLY STATED, THE LIGHT HEAD HAS FALLEN DURING A RENAL TRANSPLANT AND HIT THE SURGEON ON THE HEAD AND LANDED ON A PATIENT. INITIALLY, THERE WAS NO INFORMATION PROVIDED REGARDING ANY INJURIES. NEVERTHELESS, WE HAVE DECIDED TO REPORT THIS COMPLAINT TO COMPETENT AUTHORITIES BASED ON THE POTENTIAL FOR HAZARDOUS SITUATION OCCURRENCE DUE TO THE SURGICAL LIGHT FALLING OFF THE CEILING. FURTHER ON, WE HAVE RECEIVED ADDITIONAL INFORMATION AND WERE ABLE TO CONCLUDE THE FOLLOWING: THE DOCTOR DID NOT SUSTAIN ANY SERIOUS INJURY, HOWEVER A DAY AFTER, HE FELT ¿LIKE HE HAD A CAR ACCIDENT¿. THE PATIENT HAS BEEN TREATED WITH WASHOUT AT THE TIME OF SURGERY AND A LENGTHY ANTIBIOTIC REGIME AFTERWARDS. THESE ACTIONS TAKEN COULD BE DEFINED AS MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEREFORE BASED ON THIS NEW INFORMATION THE CLASSIFICATION OF THE INCIDENT HAS BEEN CHANGED TO CORRECTLY REFLECT THE OUTCOME. AFTER THE INCIDENT OCCURRENCE, THE COMPANY¿S REPRESENTATIVE EVALUATED THE SPRING ARM AND CONFIRMED NO EVIDENCE OF THE SINGLE COLLAR RETAINING SCREW BEING IN PLACE WHEN THE INCIDENT TOOK PLACE HAS CHECKED THE DEVICE. SUCH ABSENCE WOULD HAVE RESULTED IN THE RETAINING COLLAR MOVING UPWARDS FROM ITS CORRECT POSITION, CAUSING THE RETAINING SEGMENT TO BECOME DISLODGE AND, IN CONSEQUENCE, ALLOWING THE LAMP HEAD TO DISCONNECT. THE LIGHT HEAD WAS REINSTALLED AND TESTED- AND FOUND OPERATIONAL AND FUNCTIONAL. THE INSTALLATION DATE OF THE DEVICE IS 6TH FEBRUARY, 2018 AND IT HAS BEEN CONFIRMED THAT INSTALLATION PROCEDURE WAS COMPLETED BY APPROVED PERSONNEL AND IN ACCORDANCE TO THE MANUFACTURER¿S INSTRUCTION. WHEN THE EVENT OCCURRED, THE LIGHT HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT, FOR POWERLED DEVICES, THE OCCURRENCE RATE FOR THE ISSUE OF THE SAFETY SLEEVE MOVING DUE TO A MISSING SCREW IS LOW (TOTAL OF 4 COMPLAINTS IN THE LAST 5 YEARS OF DAILY USE OF A LARGE NUMBER OF SIMILAR DEVICES). THE ISSUE MOST LIKELY OCCURRED DUE TO OCCURRENCE OF ONE OF FOLLOWING FACTORS OR COMBINATION OF BOTH: TIGHTENING ISSUE DURING INSTALLATION AND/OR AFTER INSTALLATION AN UNAPPROVED MODIFICATION WAS DONE BY A PERSON WHO HAVE REMOVED/RE-TIGHTENED WRONGLY THE SCREW. IT IS WORTH TO BE NOTED THAT DUE TO THE IMPORTANCE OF PROPER ADJUSTMENT OF THE SAFETY SEGMENT THERE IS AN ADDITIONAL LABEL ADDED ON THE SURGICAL LIGHT, WHICH WARNS THE USER ABOUT THE NECESSITY FOR SLEEVE BEING SECURED BY THE SCREW. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THE OCCURRENCE RATE IS CONSIDERED TO BE LOW WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. 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. (B)(6)
ON (B)(4) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWER LED. AS IT WAS STATED, LIGHT HEAD HAS FALLEN DURING A RENAL TRANSPLANT AND HIT THE SURGEON ON THE HEAD AND LANDED ON PATIENT. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART WHICH MAY FALL MIGHT CAUSE AN INJURY. (B)(4).
REF: (B)(4); TW # (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
REF- (B)(4).
REF- (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857757 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |