SUSPENSION DOUBLE SAHORFS
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Report
- Report Number
- 9710055-2022-00212
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- May 24, 2022
- Report Date
- June 15, 2022
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ON (B)(6) 2022, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACEMENT IS REQUIRED. TAKING INTO CONSIDERATION THE INITIALLY PROVIDED LIMITED DETAILS, THE ISSUE WAS NOT CONSIDERED RISK OR SAFETY RELATED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON (B)(6)THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS (B)(6) 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON (B)(6) INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE DETACHMENT OF THE SCREW OCCURRED DURING THE INTENTIONAL DISASSEMBLY PROCESS, WHEN THE DEVICE WAS OUT OF SERVICE AND UNDER THE TECHNICIAN¿S CONTROL. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. ACCORDING TO THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN, THE DEVICE HAS BEEN REPAIRED BY REPLACEMENT OF FAULTY SPRING ARM. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION, SINCE A FAULTY SPRING ARM COULD BE CONSIDERED A TECHNICAL DEFICIENCY. AS THE ISSUE WAS NOT CONSIDERED SAFETY-RELATED, THE DEVICE DID NOT CONTRIBUTE TO EVENT. IT IS UNKNOWN IF THE CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE ISSUE OCCURRED. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUES HAVE NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. ACCORDING TO THE SUBJECT MATTER EXPERT¿S EVALUATION, THE PROBABLE REASON OF THIS MALFUNCTION IS A MODIFICATION OF THE ORIGINAL PRODUCT, NOT APPROVED BY THE FACTORY. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACE IS REQUIRED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON (B)(6) THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS (B)(6) 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON (B)(6) INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2022, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACEMENT IS REQUIRED. TAKING INTO CONSIDERATION THE INITIALLY PROVIDED LIMITED DETAILS, THE ISSUE WAS NOT CONSIDERED RISK OR SAFETY RELATED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON (B)(6) JUNE THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS (B)(6) 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON (B)(6) INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE DETACHMENT OF THE SCREW OCCURRED DURING THE INTENTIONAL DISASSEMBLY PROCESS, WHEN THE DEVICE WAS OUT OF SERVICE AND UNDER THE TECHNICIAN¿S CONTROL. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.
THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 24TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 24TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACE IS REQUIRED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON 7TH JUNE THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS 7TH JUNE 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 8TH JULY INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. 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.
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.
ON (B)(6) 2022, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACEMENT IS REQUIRED. TAKING INTO CONSIDERATION THE INITIALLY PROVIDED LIMITED DETAILS, THE ISSUE WAS NOT CONSIDERED RISK OR SAFETY RELATED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON (B)(6) THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS (B)(6) 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON (B)(6) INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE DETACHMENT OF THE SCREW OCCURRED DURING THE INTENTIONAL DISASSEMBLY PROCESS, WHEN THE DEVICE WAS OUT OF SERVICE AND UNDER THE TECHNICIAN¿S CONTROL. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
ON 24TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
ON 24TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL HOLDER - SUSPENSION DOUBLE SAHORFS. INITIALLY THERE WAS INFORMATION THAT DEVICE IS BROKEN AND THE REPLACE IS REQUIRED. AFTER THE VISIT OF GETINGE TECHNICIAN IN THE FACILITY ON 7TH JUNE THE ADDITIONAL INFORMATION WAS PROVIDED. IT WAS STATED THE SCREW WAS DETACHED FROM ARM AND FELL ON THE FLOOR. THE ADVERSE EVENT AWARE DATE WAS ESTIMATED AS 7TH JUNE 2022. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 8TH JULY INDICATED THAT THE SCREW FALL OUT DURING DISMANTLING. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2156924 | SUSPENSION DOUBLE SAHORFS | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567912907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |