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

Model Number ARD568821962

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/10/2021

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) 2021 getinge became aware of an issue with one of the surgical lights - volista.It was stated that during surgery paint was peeling from fork and fell into sterile field.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.

Manufacturer Narrative

The correction of d4 catalog # deems required.This is based on the internal evaluation.Previous d4 catalog # ard568821962.Corrected d4 catalog # ard56821962.Getinge became aware of an issue with volista standop surgical light.It was stated by the customer¿s clinical staff that during surgery paint peeled from fork and fell into sterile field.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.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since appearance of paint peeling could be considered as technical deficiency, and in this way devices contributed to event.Claimed device was used for patient treatment when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a low ratio.The peeling paint was caused by a lack of paint adhesion due to the painting process, the surface was too smooth after nitrocarburizing and the paint did not adhere correctly.The surface treatment of the axle involved was performed, by: manual mechanical cleaning with sanding sponge carborundom p240.In order to improve the paint adhesion, the supplier ¿larm a.S.¿ implemented modifications in the technological process for the metal surface treatment before painting; since february 2020, s70 abrasive ball blasting is applied, increasing the roughness of the surface and ensuring paint adhesion.This step is an automatic process reducing human factor.To prevent any safety issue the user manual ifu 01781 en 13 page 37 mentions to check for any chipped or missing paint during daily inspection.Additional inspection shall be performed as a part of the maintenance monthly inspection (§ 8.1.1 of the user manual ifu 01781 en 13 page 94).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The correction of additional mfg narrative/corr.Data# field deem required.This is based on the internal evaluation.#h10 previous additional mfg narrative/corr.Data: getinge became aware of an issue with volista standop surgical light.It was stated by the customer¿s clinical staff that during surgery paint peeled from fork and fell into sterile field.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.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since appearance of paint peeling could be considered as technical deficiency, and in this way devices contributed to event.Claimed device was used for patient treatment when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a low ratio.The peeling paint was caused by a lack of paint adhesion due to the painting process, the surface was too smooth after nitrocarburizing and the paint did not adhere correctly.The surface treatment of the axle involved was performed, by: manual mechanical cleaning with sanding sponge carborundom p240.In order to improve the paint adhesion, the supplier ¿(b)(4)¿ implemented modifications in the technological process for the metal surface treatment before painting; since february 2020, s70 abrasive ball blasting is applied, increasing the roughness of the surface and ensuring paint adhesion.This step is an automatic process reducing human factor.To prevent any safety issue the user manual ifu 01781 en 13 page 37 mentions to check for any chipped or missing paint during daily inspection.Additional inspection shall be performed as a part of the maintenance monthly inspection (§ 8.1.1 of the user manual ifu 01781 en 13 page 94).Corrected additional mfg narrative/corr.Data: getinge became aware of an issue with volista standop surgical light.It was stated by the customer¿s clinical staff that during surgery paint peeled from fork and fell into sterile field.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.Based on information provided by the getinge technician, the issue was solved on warranty terms.As a result, replacement parts were delivered to the customer.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since appearance of paint peeling could be considered as technical deficiency, and in this way devices contributed to event.Claimed device was used for patient treatment when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a low ratio.As stated by the subject matter expert at manufacturer¿s, the peeling paint was caused by a lack of paint adhesion due to the painting process, the surface was too smooth after nitrocarburizing and the paint did not adhere correctly.The surface treatment of the axle involved was performed, by: manual mechanical cleaning with sanding sponge carborundom p240.In order to improve the paint adhesion, the supplier ¿(b)(4).¿ implemented modifications in the technological process for the metal surface treatment before painting; since february 2020, s70 abrasive ball blasting is applied, increasing the roughness of the surface and ensuring paint adhesion.This step is an automatic process reducing human factor.To prevent any safety issue the user manual mentions to check for any chipped or missing paint during daily inspection.Additional inspection shall be performed as a part of the maintenance monthly inspection.Getinge initiated a field action msa-605552 (z-1308-2022) in may 2022 for the volista standop surgical lights due to the potential for paint chipping to occur on the component (reference (b)(4)) located on the fork of the volista standop cupolas.Field action was launched in order to continue to perform daily inspections per the ifu by the customers, which include checking for any chipped or missing paint.If customer observes paint chipping or detachment, getinge recommends to stop using the device and contact getinge service representative to schedule an appointment to replace the part free of charge.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• 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: 13150547
• MDR Text Key: 283138861
• Report Number: 9710055-2022-00002
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568821962
• Device Catalogue Number: ARD56821962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/12/2022; 06/30/2022
• Supplement Dates FDA Received: 01/27/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1308-2022
• Patient Sequence Number: 1