HLED 500
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Report
- Report Number
- 9710055-2023-00306
- Event Type
- Malfunction
- Date Received
- April 13, 2023
- Date of Event
- March 23, 2023
- Report Date
- April 13, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 23TH MARCH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - S/E BRAS DOUBLE VIDEO HD SALDUOHD. IT WAS STATED THE LOCKING PIN MISSING RESULTING HANDLE DETACHMENT FROM THE LIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 23TH MARCH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - HLED 500. IT WAS STATED THE LOCKING PIN MISSING RESULTING HANDLE DETACHMENT FROM THE LIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. THE CORRECTION OF D1 BRAND NAME, D2A PRODUCT CODE, D4 CATALOG #, MODEL # AND SERIAL # DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # AND MODEL # ARD567910968. CORRECTED D4 CATALOG # AND MODEL # ARD568351959/ARD567910968. PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6). PREVIOUS D1 BRAND NAME: S/E BRAS DOUBLE VIDEO HD SALDUOHD. CORRECTED D1 BRAND NAME: HLED 500. PREVIOUS D2A PRODUCT CODE: FXR. CORRECTED D2A PRODUCT CODE: FSY.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - HLED 500. AS IT WAS STATED THE LOCKING PIN HAS BEEN MISSING RESULTING IN HANDLE DETACHMENT FROM THE LIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE FAULTY HANDLE OF THE AFFECTED SURGICAL LIGHT (ARD368402998 HLED 500/700-S/A HANDLE HOLDER QL) WAS REPLACED. EQUIPMENT WAS TESTED TO FACTORY SPECIFICATIONS AND RELEASED FOR USE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION, DUE TO LOCKING PIN MISSING BEING MISSING AND RESULTING IN HANDLE DETACHMENT FROM THE LIGHT. SUCH A SCENARIO COULD BE CONSIDERED AS TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, IT WAS CONFIRMED THAT IN THE LAST 5 YEARS, REGISTERED FOR THE ISSUE OF HANDLE DETACHMENT ON POWERLED AND HLED SURGICAL LIGHTS THERE WAS NO SERIOUS INJURY OR WORSE REPORTED. COMPARING THE NUMBER OF CLAIMED DEVICES TO THE NUMBER OF SOLD DEVICES WORLDWIDE, WE CAN ASSUME THAT THE FAILURE RATIO OF THE HANDLE DETACHMENT IS LOW. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE. THEY STATED THAT THE STERIZABLE HANDLE FALL IS DUE TO LOCKING MECHANISM DISENGAGEMENT. TWO POSSIBLE CAUSES HAVE BEEN IDENTIFIED: - FIRST CAUSE: WRONG POSITIONING OF THE CIRCLIP IN ITS SLOT. - SECOND CAUSE: BREAKAGE OF THE CIRCLIP BECAUSE OF OXIDATION. THE FIRST CAUSE CAN BE RULED OUT BECAUSE SINCE NOVEMBER 2012 CIRCLIP ASSEMBLY OPERATION IS CHECKED AT 100% AT THE SUPPLIER. THE SECOND CAUSE (CIRCLIP BREAKAGE BECAUSE OF OXIDATION) IS THEN THE MOST PROBABLE ROOT CAUSE. THE CURATIVE AND PREVENTIVE ACTION PLAN N° 2015-06 HAS BEEN INITIATED TO IDENTIFY THE REASON OF THIS OXIDATION. THEN, IT HAS BEEN DECIDED TO IMPROVE THE CURRENT CIRCLIP MATERIAL STAINLESS STEEL A2 BY STAINLESS STEEL A4 MORE RESISTANT TO CHEMICALS. THE 2 TEST BATCHES SENT IN BRAZIL AND GERMANY AND THE SALT SPRAY TESTS MADE IN LABORATORY PROVE THAT CIRCLIPS MADE IN STAINLESS STEEL A4 SOLVE THE OXIDATION TROUBLES. AS AN EFFECT OF RECEIVED RESULTS, THE MODIFICATION HAS BEEN APPLIED IN OUR PRODUCTION LINE SINCE (B)(6) 2017. THE AFFECTED DEVICE WHICH CONTRIBUTED TO THE MALFUNCTION INVESTIGATED HEREIN WAS MANUFACTURED ON 3RD AUGUST 2016, THEREFORE, THE SECOND CAUSE IS CONSIDERED AS THE MOST POSSIBLE SCENARIO. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
EVENT SITE NAME: (B)(6). DEVICE NOT RETURNED TO MANUFACTURER.
ON 23TH MARCH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - HLED 500. IT WAS STATED THE LOCKING PIN MISSING RESULTING HANDLE DETACHMENT FROM THE LIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
ON 23TH MARCH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - S/E BRAS DOUBLE VIDEO HD SALDUOHD. IT WAS STATED THE LOCKING PIN MISSING RESULTING HANDLE DETACHMENT FROM THE LIGHT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1597950 | HLED 500 | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD568351959/ARD567910968 | ||
| 980015 | HLED 500 | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD568351959/ARD567910968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |