XS SINGLE FLAT SCREEN HOLDER
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Report
- Report Number
- 9710055-2023-00533
- Event Type
- Malfunction
- Date Received
- July 21, 2023
- Report Date
- July 21, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, D1 BRAND NAME, D2 PRODUCT CODE., D4 VERSION OR MODEL #, D4 CATALOG #, D4 SERIAL# DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE HANDLE HOLDER WAS MISSING FROM MONITOR ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE HOLDER WAS MISSING FROM MONITOR ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. PREVIOUS D1 BRAND NAME: POWERLED 700 CORRECTED D1 BRAND NAME: XS SINGLE FLAT SCREEN HOLDER PREVIOUS D2 PRODUCT CODE. FSY CORRECTED D2 PRODUCT CODE. FXR PREVIOUS D4 VERSION OR MODEL # POWERLED - OTHER CORRECTED D4 VERSION OR MODEL # ARD567506996 PREVIOUS D4 CATALOG # ARD568371938 CORRECTED D4 CATALOG # ARD567506996 PREVIOUS D4 SERIAL (B)(6) CORRECTED D4 SERIAL (B)(6). 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 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. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE HOLDER WAS MISSING FROM MONITOR ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. THE DEVICE HAS BEEN REPAIRED BY REPLACEMENT OF HANDLE HOLDER (ARD567701135) AND RETURNED TO USE. 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. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. AT THE DELIVERY THE HANDLE DISC IS NOT FITTED ON THE SCREEN HOLDER BUT DELIVERED SEPARATELY IN A LITTLE PLASTIC BAG INCLUDING A KIT WITH OTHER PARTS. THE INSTALLATION MANUAL INDICATES ITS MOUNTING AT THE DEVON HANDLE INSTALLATION STEP. THE MOST LIKELY ROOT CAUSE REGARDING THIS CASE IS AN OVERSIGHT DURING INSTALLATION OR MAINTENANCE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY.
ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE HANDLE HOLDER WAS MISSING FROM MONITOR ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.
ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE HOLDER WAS MISSING FROM MONITOR ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1530946 | XS SINGLE FLAT SCREEN HOLDER | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 | ||
| 2254878 | XS SINGLE FLAT SCREEN HOLDER | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |