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

Model Number ARD568811960

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

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023 getinge received a service call placed by the customer regarding deficiency with one of our surgical lights - volista standop.At this point none of the provided information were indicating a safety related event.Further information became available on (b)(6) 2023 following the repair visit at the customer site.It has been confirmed by our service technician the rust occurred on the device.We decided to report the issue in abundance of caution as rust may lead to particles falling off into the sterile field and consequently to contamination.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 13th january, 2023 getinge received a service call placed by the customer regarding deficiency with one of our surgical lights - volista standop.At this point none of the provided information were indicating a safety related event.Further information became available on 6th february 2023 following the repair visit at the customer site.It has been confirmed by our service technician the rust occurred on the device.We decided to report the issue in abundance of caution as rust may lead to particles falling off into the sterile field and consequently to contamination.Corrected b5 describe event and problem: on 13th january, 2023 getinge received a service call placed by the customer regarding deficiency with one of our surgical lights - volista standop.At that point none of the provided information were indicating a safety related event.Further information became available on 6th february 2023 following the repair visit at the customer site.It has been confirmed by our service technician the paint peeling and rust occurred on the device.We decided to report the issue in abundance of caution as rust may lead to particles falling off into the sterile field and consequently to contamination.On 13th january, 2023 getinge received a service call placed by the customer regarding deficiency with one of our surgical lights - volista standop.At that point none of the provided information were indicating a safety related event.Further information became available on 6th february 2023 following the repair visit at the customer site.It has been confirmed by our service technician the paint peeling and rust occurred on the device.We decided to report the issue in abundance of caution as rust may lead to particles falling off into the sterile field and consequently to contamination.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since rust occurrence and paint chipping could be considered as technical deficiencies, and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.When reviewing reportable events for paint peeling issues we were able to establish that the received incidents are occurring at a moderate ratio and low for rust issue.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the subject matter expert at the manufacturer site, the most probable root cause of this premature oxidation and paint degradation would be an incorrect operation handling before painting.The pre-treatment operation could be involved.The improper protection after rust or incompletely dry after rust process would have led to the containment and oxidization under the paint.So far, all the cases reported correspond to main arms manufactured before july 2016, hence by the supplier fengmi.The painting suppliers have changed since july 2016.The current one is huaya who has strengthened the process and parameters stability.No cases have been reported since the supplier fengmi has been replaced.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 13th january, 2023 getinge received a service call placed by the customer regarding deficiency with one of our surgical lights - volista standop.At that point none of the provided information were indicating a safety related event.Further information became available on 6th february 2023 following the repair visit at the customer site.It has been confirmed by our service technician the paint peeling and rust occurred on the device.We decided to report the issue in abundance of caution as rust may lead to particles falling off into the sterile field and consequently to contamination.

• 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: 16458452
• MDR Text Key: 310419066
• Report Number: 9710055-2023-00143
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568811960
• Device Catalogue Number: ARD568811960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1