XHS0
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Report
- Report Number
- 9710055-2023-00506
- Event Type
- Malfunction
- Date Received
- July 12, 2023
- Date of Event
- July 5, 2023
- Report Date
- July 12, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE CORRECTION OF THE INITIALLY PROVIDED INFORMATION. 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 OR PROBLEM, D1 BRAND NAME, D2 COMMON DEVICE NAME, D4 VERSION OR MODEL #, CATALOG #, SERIAL # AND H4 DEVICE MANUFACTURE DATE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 5TH JULY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II 700/500. AS IT WAS STATED, THE HANDLE OF A MONITOR CAME OFF DURING PREPARATION FOR THE SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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 OR PROBLEM: ON 5TH JULY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENTS ¿ XHS0. AS IT WAS STATED, THE HANDLE OF A MONITOR CAME OFF DURING PREPARATION FOR THE SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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 II. CORRECTED D1 BRAND NAME: XHS0. PREVIOUS D2 COMMON DEVICE NAME: FTD LAMP, SURGICAL. CORRECTED D2 COMMON DEVICE NAME: FXR HOLDER, CAMERA, SURGICAL. PREVIOUS D4 VERSION OR MODEL #: ARD569241917/ARD569242913. CORRECTED D4 VERSION OR MODEL #: ARD567712901. PREVIOUS D4 CATALOG #: ARD569241917/ARD569242913. CORRECTED D4 CATALOG #: ARD567712901. PREVIOUS D4 SERIAL #: (B)(6)/(B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS H4 DEVICE MANUFACTURE DATE: 08/23/2022. CORRECTED H4 DEVICE MANUFACTURE DATE: 08/12/2022.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1H EVENT SITE POSTAL CODE: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND 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 OUR EQUIPMENTS ¿ XHS0. AS IT WAS STATED, THE HANDLE OF A MONITOR CAME OFF DURING PREPARATION FOR THE SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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. 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. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED DURING PREPARATION TO THE SURGERY. AS STATED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE, THE DETACHMENT BETWEEN HANDLE HOLDER AND ALUMINUM CYLINDER, WHICH ALLOWS BONDING OF THE HANDLE, IS PROBABLY DUE TO MECHANICAL SHOCKS, COLLISIONS OR EXCESSIVE EFFORTS. TO PREVENT ANY SIMILAR INCIDENT, THE FOLLOWING HAVE BEEN IMPLEMENTED: - DURING THE MANUFACTURING THE PRATS ARE DEGREASED - THE QUANTITY OF THE INSTANT ADHESIVE GEL DEPOSITED IS CHECKED - THE ADHESIVE BONDING IS CHECKED BY MANUAL TRACTION DURING THE MANUFACTURING - THE USER MANUAL (B)(4) XS/XD FLAT SCREEN MONITORS HOLDERS MENTIONS TO CHECK THE CONDITION OF THE STERILIZABLE HANDLE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
ON 5TH JULY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENTS ¿ XHS0. AS IT WAS STATED, THE HANDLE OF A MONITOR CAME OFF DURING PREPARATION FOR THE SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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 5TH JULY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ POWERLED II 700/500. AS IT WAS STATED, THE HANDLE OF A MONITOR CAME OFF DURING PREPARATION FOR THE SURGERY. THERE WAS NO INJURY REPORTED, HOWEVER, 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 |
|---|---|---|---|---|---|---|---|
| 249648 | XHS0 | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567712901 | ||
| 987798 | XHS0 | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567712901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |