MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL

Model Number ARD568811911

Device Problems Corroded (1131); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On 19th may, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was chipping from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event or problem 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 lights - volista standop.It was stated the paint was chipping from the spring arm.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on (b)(6), 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was chipping from the spring arm.On (b)(6) 2022 the photos with visible rust occurrence were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.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.

Event Description

On (b)(6), 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was chipping from the spring arm.On (b)(6) 2022 the photos with visible rust occurrence were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

The correction of b5 describe event or problem deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 19th may, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was chipping from the spring arm.On (b)(6) 2022 the photos with visible rust occurrence were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 24th march 2022 getinge became aware of an issue with one of the surgical lights - volista standop.As it was stated, paint was chipping from the spring arm.On (b)(6) 2022 the photos with visible rust occurrence and paint chipping on suspension arm, fork and main tube were recived.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Initially, the issue was reported under ot (b)(4) (report #9710055-2019-00025) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.Getinge became aware of an issue with one of the surgical lights - volista standop.It was stated based on the received photos that the paint was chipping from the spring arm, suspension arm, fork and main tube as well as rust was detected on these components.We decided to report the issue in abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.Initially, the issue was reported under (b)(4) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since appearance of paint peeling and corrosion could be considered as technical deficiency, and in this way devices contributed to event.It remains unknown whether the affected device was or was not being used for patient treatment or diagnosis when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low ratio.As stated by subject matter expert at the manufacturer¿s site, the oxidation has been detected between the fork and the sleeve of spring arm.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.This event is clearly due to the cleaning product.Nevertheless, the deterioration of the paint is far advanced and it must have started years ago.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.The damaged parts must be replaced as soon as possible.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.On 24th march 2022 getinge became aware of an issue with one of the surgical lights - volista standop.As it was stated, paint was chipping from the spring arm.On 8th june 2022 the photos with visible rust occurrence and paint chipping on suspension arm, fork and main tube were recived.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Initially, the issue was reported under (b)(4).(report #9710055-2019-00025) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.

Event Description

On 24th march 2022 getinge became aware of an issue with one of the surgical lights - volista standop.As it was stated, paint was chipping from the spring arm.On (b)(6) 2022 the photos with visible rust occurrence and paint chipping on suspension arm, fork and main tube were recived.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Initially, the issue was reported under (b)(4) (report #9710055-2019-00025) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.

• Brand Name: VOLISTA STANDOP
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14468605
• MDR Text Key: 292354926
• Report Number: 9710055-2022-00166
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568811911
• Device Catalogue Number: ARD568811911
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1