MAUDE Adverse Event Report: VOLISTA TRIOP; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568802961

Device Problems Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 21st january 2021 getinge became aware of an issue with one of our surgical light - volista triop.As it was stated customer reported abnormal movement of the double fork mounting hinge.Inspection of the device revealed loosened screws and also damaged grounding bracket.No information about any injury was provided however we decided to report this case in abundance of caution as any loosening of the screws could led to detachment of the device and this further may led to serious injury.

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of manufacture date section.This is based on the result of an internal review.#h4: previous manufacture date: 06/01/2015.Corrected manufacture date: 06/25/2015.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with a surgical light volista device.As it was stated customer reported abnormal movement of the double fork mounting hinge and damaged grounding screw.The company representative, who visited the site and the photographic evidence of the issue that has been provided were in line with alleged issue.It was established that when the event occurred, the surgical light did not meet its specification as abnormal movement, loosened screw and damaged grounding screw could be treated as technical deficiency.The device state directly contributed to the reported event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.An abnormal movement between the fork and the vertical support has been detected during the use of the product (abnormal movement between compensation arm and lighthead fork).The investigation was made by the field service technician and he found that one screw out of the three fixing screws was missing.The lighthead cannot fall down as it is fixed by the two remaining screws.The yearly preventive maintenance program documented in the technical manual 0175201, mentions to check the stability of the system in all positions.The product has been repaired by the field service technician.To avoid any similar issue the yearly preventive maintenance must be performed according to the manufacturer recommendations.In 2012, mechanical tests carried out on the complete triop volista configuration and the tests were conforming to the standard iec 60601-1-ed.2 & 3 and ul 60601-1 ed.1 (cre12-120).The limit stop effectiveness of the vertical support was part of these tests.Then the most probable root cause of the black screw location damage is repeating and violent shocks during the use of the device (lighthead rotation).In the technical manual 0175201, it is mentioned to check the effectiveness of limit stops and to achieve the continuity test during the yearly preventive maintenance.The vertical support assembly is no longer available in our spare parts list then the repair is not possible.Therefore, maquet sas recommends the replacement of the operating light configuration.Exact root cause of the issue with loosened screw could not be established while damaged grounding could be caused by improper use.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: VOLISTA TRIOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 11293205
• MDR Text Key: 230723760
• Report Number: 9710055-2021-00049
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

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 Operator: No Information
• Device Model Number: ARD568802961
• Device Catalogue Number: ARD568802961
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 04/12/2021
• Supplement Dates FDA Received: 02/25/2021; 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1