POWERLED
Report
- Report Number
- 9710055-2018-00093
- Event Type
- Malfunction
- Date Received
- October 5, 2018
- Date of Event
- August 3, 2018
- Report Date
- February 21, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS #1 FOLLOW-UP REPORT IS BEING SENT AS THE INITIAL SUBMISSION CONTAINED AN INCORRECT DATE AWARE DATE REFERENCE IN SECTION B AND G. THE AWARE DATE IN SECTION B WAS NOTED AS (B)(6)2018 INSTEAD OF (B)(6) 2018. SECTION G -DATE RECEIVED BY MANUFACTURER WAS ALSO INCORRECTLY NOTED AS (B)(6) 2018 INSTEAD OF (B)(6)2018. THIS FOLLOW-UP REPORT SERVES TO CORRECT BOTH ERRORS. 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.
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. MAQUET SAS BECAME AWARE OF AN ISSUE WITH SURGICAL LIGHT POWERLED 300 DEVICE. AS IT WAS STATED BY THE CUSTOMER, THE CIRCLIP BROKE ON THE HANDLE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL RELATED TO FALLING PARTS BEING POTENTIAL SOURCE OF CONTAMINATION. DURING THE INVESTIGATION IT WAS FOUND THAT WE HAVE RECEIVED SIMILAR COMPLAINTS IN THE PAST, HOWEVER NONE OF THEM HAVE LED TO SERIOUS INJURY OR WORSE. IN THE LAST 5 YEARS, ALL COMPLAINTS RECEIVED ON THAT FAILURE WERE ORIGINATED FROM GERMANY. THE INVOLVED HANDLE IS USED TO MANEUVER THE SURGICAL LIGHT TO CORRECTLY SET THE LIGHT¿S ILLUMINATION OVER THE SURGICAL AREA. IT WAS ESTABLISHED THAT WHEN THE ISSUE OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE COMPLAINT. IT WAS NOT ESTABLISHED IF THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT AT THE TIME OF ISSUE OCCURRENCE. THE FIXATION HANDLE IS A PART THAT IS EASILY REMOVABLE AND MUST BE STERILIZED IN A STERILIZER AFTER EACH SURGICAL PROCEDURE. THE LOCKING MECHANISM IS COMPOSED BY A STEEL AXIS, A SPRING AND A CIRCLIP. IT WAS REPORTED THAT A PART OF THE LOCKING MECHANISM ON THE HANDLE (CIRCLIP) WAS BROKEN. IT WAS CONFIRMED BY TESTS RESULTS THAT THE MOST LIKELY ROOT CAUSE OF THE BREAKAGE OF CIRCLIPS IS CORROSION OF A2 STEEL. THEREFORE, IT WAS DECIDED TO CHANGE THE MATERIAL TO A4 STAINLESS STEEL.
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).
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. THE SCREW AND NUT CAME OFF OF THE HANDLE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. THE SCREW AND NUT CAME OFF OF THE HANDLE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT BE A SOURCE OF CONTAMINATION. (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).
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).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 778271 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD568330933 | ||
| 778272 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD568330933 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |