SPRING ARM
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Report
- Report Number
- 9710055-2022-00233
- Event Type
- Malfunction
- Date Received
- June 24, 2022
- Date of Event
- June 9, 2022
- Report Date
- June 24, 2022
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SPRING ARMS. BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN IT WAS STATED THAT THE SPRING ARM COVER WAS CRACKED, HOWEVER, THERE WERE NO EXTRA FACTORS THAT WOULD LEAD US TO EVALUATE THE SITUATION AS REPORTABLE AND THE ISSUE WAS SEEN AS A COMPLAINT, ONLY. THE DEFECTIVE COVER WAS REPLACED BY THE TECHNICIAN. ON 9TH JUNE 2022, ADDITIONAL INFORMATION WAS RECEIVED POINTING TO THE APPARENT ISSUE OF A LABEL MISSING ON THE EXCHANGED SPARE PART, WHICH WAS INITIALLY CONSIDERED AS REPORTABLE EVENT, SINCE THERE APPEARED TO BE POTENTIAL THAT MAY HAVE COME OFF DURING USE OVER A SURGICAL AREA. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER COMMUNICATION WITH GETINGE TECHNICIAN, AND FURTHER INVESTIGATION, ALLOWED US TO ESTABLISH AND CONFIRM THAT THE REPLACED PART IS A SPARE PART WHICH DOES NOT HAVE ANY LABELLING. THEREFORE, THERE WAS NO RISK OF ANY LABEL FALLING OFF INTO STERILE FIELD, AFTER ALL. WHEN THE SUSPECTED MALFUNCTION WAS THOUGHT TO HAVE OCCURRED, THE DEVICE WAS NOT BEING USED FOR PATIENT CARE, IT WAS UP TO THE MANUFACTURER SPECIFICATION AND IN THE END DID NOT CONTRIBUTE TO ANY EVENT. APART FOR THE CRACKED COVER, HOWEVER, AFTER REPLACING OR ADJUSTING THE COMPONENT THE DEVICE COULD RETURN TO NORMAL USE. AS STATED BY SUBJECT MATTER EXPERT AT MANUFACTURING SITE, THERE IS NO LABEL PRESENT ON THE COVERS WITH PART NUMBER (B)(6) WHICH WAS REPLACED BY GETINGE TECHNICIAN. GETINGE TECHNICIAN INITIALLY REPORTED LACK OF THE LABEL BUT HE DID NOT CLEARLY STATED THAT HE REFERRED TO THE SPARE PART, NOT THE SURGICAL LIGHT ITSELF. THEREFORE, BASED ON THIS, THERE WAS NO RISK OF CONTAMINATION THE STERILE FIELD DUE TO MISSING LABEL FROM THIS PART. ADDITIONALLY, AS THERE WAS NO PHOTOGRAPHIC EVIDENCE PROVIDED NOR DETAILED INFORMATION ABOUT THE MALFUNCTION, IT IS NOT POSSIBLE TO DETERMINE THE MOST PROBABLE ROOT CAUSE OF CRACKED SPRING ARM¿S COVER. HAVING REVIEWED THE INFORMATION PROVIDED TO THE CUSTOMER PRODUCT COMPLAINT COMPLAINT HANDLER DID NOT IDENTIFY ANY APPARENT REASON SUGGESTING TO OPEN A CAPA OR EVALUATION FOR THE NEED OF AN ACTION IN THE MARKET. IT IS NOT LIKELY THAT IT COULD LEAD TO THE SERIOUS INJURY OR DEATH WHEN THE MALFUNCTION REOCCURS. THAT IS WHY IT IS NOT CONSIDERED TO BE SAFETY RELATED AND REPORTABLE. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM AND H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 23RD MARCH 2022 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SPRING ARMS. ON 9TH JUNE 2022, ADDITIONAL INFORMATION WAS RECEIVED POINTING TO REPORTABLE ISSUE - MISSING LABEL. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 23RD MARCH 2022 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SPRING ARMS. BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN IT WAS STATED THAT THE SPRING ARM COVER WAS CRACKED, HOWEVER, THERE WERE NO EXTRA FACTORS THAT WOULD LEAD US TO EVALUATE THE SITUATION AS REPORTABLE AND THE ISSUE WAS SEEN AS A COMPLAINT, ONLY. THE DEFECTIVE COVER WAS REPLACED BY THE TECHNICIAN. ON 9TH JUNE 2022, ADDITIONAL INFORMATION WAS RECEIVED POINTING TO THE APPARENT ISSUE OF A LABEL MISSING ON THE EXCHANGED SPARE PART, WHICH WAS INITIALLY CONSIDERED AS REPORTABLE EVENT, SINCE THERE APPEARED TO BE POTENTIAL THAT MAY HAVE COME OFF DURING USE OVER A SURGICAL AREA. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER COMMUNICATION WITH GETINGE TECHNICIAN, AND FURTHER INVESTIGATION, ALLOWED US TO ESTABLISH AND CONFIRM THAT THE REPLACED PART IS A SPARE PART WHICH DOES NOT HAVE ANY LABELLING. THEREFORE, THERE WAS NO RISK OF ANY LABEL FALLING OFF INTO STERILE FIELD, AFTER ALL. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE. MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE. NO APPARENT ADVERSE EVENT///3189.
ON (B)(6) 2022 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SPRING ARMS. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED POINTING TO REPORTABLE ISSUE - MISSING LABEL. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
ON 23RD MARCH 2022 GETINGE BECAME AWARE OF A NON-REPORTABLE ISSUE WITH ONE OF OUR SPRING ARMS. BASED ON INFORMATION PROVIDED BY GETINGE TECHNICIAN IT WAS STATED THAT THE SPRING ARM COVER WAS CRACKED, HOWEVER, THERE WERE NO EXTRA FACTORS THAT WOULD LEAD US TO EVALUATE THE SITUATION AS REPORTABLE AND THE ISSUE WAS SEEN AS A COMPLAINT, ONLY. THE DEFECTIVE COVER WAS REPLACED BY THE TECHNICIAN. ON 9TH JUNE 2022, ADDITIONAL INFORMATION WAS RECEIVED POINTING TO THE APPARENT ISSUE OF A LABEL MISSING ON THE EXCHANGED SPARE PART, WHICH WAS INITIALLY CONSIDERED AS REPORTABLE EVENT, SINCE THERE APPEARED TO BE POTENTIAL THAT MAY HAVE COME OFF DURING USE OVER A SURGICAL AREA. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. FURTHER COMMUNICATION WITH GETINGE TECHNICIAN, AND FURTHER INVESTIGATION, ALLOWED US TO ESTABLISH AND CONFIRM THAT THE REPLACED PART IS A SPARE PART WHICH DOES NOT HAVE ANY LABELLING. THEREFORE, THERE WAS NO RISK OF ANY LABEL FALLING OFF INTO STERILE FIELD, AFTER ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691502 | SPRING ARM | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |