MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARDSTP229003

Device Problems Crack (1135); Degraded (1153)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the headlight seal was damaged, the headlight cover was cracked and the particles were missing.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

Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the headlight seal and sleeve were damaged, with particles missing.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 information provided by getinge technician, the replacement headlight seal and sleeve has been completed.It was determined that the surgical lamp did not meet the specification at the time of the incident, as the headlight seal and sleeve were damaged with missing particles, in this way device contributed to the incident.There is no information if at the time when the event occurred the device was or was not being used for patient treatment.Comparing the number of complaints registered to the number of sold devices, we conclude that the failure ratios of the investigated issues are very low.A root cause analysis was performed by subject matter experts at manufacturing site.The information provided did not allow us to determine the cause of the deterioration.The procedure for fitting the peripheral seal is described in repair manual_01782, pages 77-78.In addition, to avoid any incident, the user's manual mentions (nu_volista_01781en_16_extract, page 30): "warning! risk of injury/infection the use of a damaged device may lead to a risk of injury for users or a risk of infection for patients.Do not use a damaged device.In addition, the user manual (nu_volista_01781en_16_extract, page 41) mentions to perform daily inspections: check that the peripheral seal is properly positioned.Visually inspect the peripheral seal.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5 describe event or problem field deems required.This is based on the additional information that has been received.Previous b5 describe event or problem: on 14th march, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the headlight seal was damaged, the headlight cover was cracked and the particles were missing.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 14th march, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the headlight seal and sleeve were damaged, with particles missing.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 14th march, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the headlight seal and sleeve were damaged, with particles missing.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

• Brand Name: VOLISTA STANDOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 13862638
• MDR Text Key: 287699163
• Report Number: 9710055-2022-00096
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDSTP229003
• Device Catalogue Number: ARDSTP229003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1