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

Catalog Number ARD568811963

Device Problem Peeled/Delaminated (1454)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 8th june, 2022 getinge became aware of an issue with one of the surgical lights - volista.It was stated that paint was peeling.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of the surgical lights ¿ volista standop.It was stated that the paint was peeling, which was confirmed by the photographic evidence.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.According to the information provided by the service technician, the issue has been temporarily solved.The offer for the replacement of the faulty fork has been presented to the customer, but it¿s pending the customer¿s approval.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the appearance of paint peeling could be considered a technical deficiency, and in that way devices contributed to the event.There is no indication if the claimed device was used for patient treatment when the issue 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.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The issues were investigated by the subject matter expert at the manufacturing site.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.The subject matter expert¿s analysis further states: the paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any incident related to paint damage issues, it is recommended to avoid collisions between devices.Visual inspections during the cleaning allow for the detection of painting defects, we recommend performing corrective maintenance to rectify the default after its detection.Minor pain chips can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.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.

• 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: 14652636
• MDR Text Key: 293715117
• Report Number: 9710055-2022-00205
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568811963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1