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

Model Number ARD267900100A

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 2nd december, 2021 getinge became aware of an issue with one of surgical lights - volista standop.The paint peeling occurred on the spring arm.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

On 2nd december, 2021 getinge became aware of an issue with one of surgical lights - volista standop.The paint peeling occurred on the spring arm.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.Corrected b5 describe event or problem: on 2nd december, 2021 getinge became aware of an issue with one of surgical lights - volista standop.The the dust cover was detached from the spring arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.Previous d4 catalog #: ard568831963, corrected d4 catalog #: ard267900100a.Previous d4 serial #: (b)(6), corrected d4 serial #: (b)(6).Previous d4 version or model #: ard568831963, corrected d4 version or model #: ard267900100a.Previous h4 manufacture date: 2018-10-24, corrected h4 manufacture date: 2018-10-25.Previous h6 medical device ¿ problem code: material integrity ,problem|degraded|peeled/delaminated|1454.Corrected h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Previous h6 component codes: mechanical|coating material||4768.Corrected h6 component codes: mechanical|cover||772.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 2nd december, 2021 getinge became aware of an issue with one of surgical lights - volista standop.The the dust cover was detached from the spring arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - volista standop.The dust cover was detached from the spring arm.There was no injury reported, however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or injury.The cover was replaced and device returned to use.It was established that when the event occurred, the surgical light did not meet its specification, since missing cover could be considered as technical deficiency, and in this way device contributed to event.The device was not being used for patient treatment or diagnosis at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of affected to number of sold devices, failure ratio is very low.According to the manufacturer¿s evaluation the possible root causes are: non-conformity of the metal covers assembly.Degradation of the metal covers.Mproper use (collision with another device).Maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe the related devices are performing correctly in the market.

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: 12947339
• MDR Text Key: 282634531
• Report Number: 9710055-2021-00369
• 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,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD267900100A
• Device Catalogue Number: ARD267900100A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1