EQT
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Report
- Report Number
- 9710055-2023-00125
- Event Type
- Malfunction
- Date Received
- February 23, 2023
- Date of Event
- February 19, 2023
- Report Date
- February 23, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM AND D2A PRODUCT CODE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 19TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP 600. AS IT WAS STATED, ONE OF THE SIX FIXATION SCREWS HOLDING THE MAIN TUBE WAS BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION AND SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 19TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT. AS IT WAS STATED, ONE OF THE SIX FIXATION SCREWS HOLDING THE SCREEN HOLDER SUSPENSION WAS BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION AND SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE. PREVIOUS D2A PRODUCT CODE: FTD. CORRECTED D2A PRODUCT CODE: FXR.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT. AS IT WAS STATED, ONE OF THE SIX FIXATION SCREWS HOLDING THE SCREEN HOLDER SUSPENSION WAS BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION AND SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE. DEFECTIVE SCREW WAS REPLACED AND DEVICE RETURNED TO USAGE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. IT WAS DISCOVERED DURING MAINTENANCE. SUBJECT MATTER EXPERT ESTABLISHED: IN CASE OF LOOSENING, THE PROBABLE CAUSES OF LOOSENING CORRESPOND TO AN IMPROPER INITIAL TIGHTENING DURING THE INSTALLATION OR A MAINTENANCE NOT IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. IN CASE OF RUPTURE, THE FAILURE OF THE SCREWS IS RELATED TO FATIGUE STRESSES DUE TO MODERATE SHEAR OVERLOAD. ALL FACIES HAVE A FATIGUE FAILURE ZONE MORE OR LESS EXTENSIVE. INITIATED AT THE BOTTOM OF THE THREAD, THE REPEATED LOW MECHANICAL STRESSES CAUSED THE BREAKAGE OF A FIRST SCREW. THE RUPTURE OF THE OTHER SCREWS CORRESPONDS TO PROGRESSIVE PROPAGATION OF THE SHEAR EFFECT. THE YEARLY PREVENTIVE MAINTENANCE PROGRAM MENTIONS: - TO CHECK THE SUSPENSION FIXING SCREWS. IT IS ALSO INDICATED TO NOT RETIGHTEN THE SCREWS DURING MAINTENANCE. IF SCREWS APPEAR LOOSENED REPLACE THEM. - TO REPLACE THE 6 FIXING SCREWS EVERY 6 YEARS. IN APRIL 2019 GETINGE TRANSMITTED THE SERVICE BULLETIN 98 ON GETINGE ONLINE REMINDING TO CARRY OUT PREVENTIVE MAINTENANCE AND WEARING PARTS REPLACEMENT TO ENSURE THE DEVICE SAFETY. THE SERVICE BULLETIN 98 MENTIONS TO REPLACE THE SUSPENSION FIXING SCREWS EVERY 6 YEARS DURING THE INSPECTION. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.
ON 19TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT. AS IT WAS STATED, ONE OF THE SIX FIXATION SCREWS HOLDING THE SCREEN HOLDER SUSPENSION WAS BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION AND SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
ON 19TH FEBRUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - VOLISTA STANDOP 600. AS IT WAS STATED, ONE OF THE SIX FIXATION SCREWS HOLDING THE MAIN TUBE WAS BROKEN. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DEFECT OF THE SCREWS INVOLVED IN THIS COMPLAINT MAY LEAD TO THE DETACHMENT OF THE WHOLE CONFIGURATION AND SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1549685 | EQT | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 | ||
| 415188 | EQT | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |