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

Catalog Number 568803913

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by the manufacturing site.

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights - volista standop.As it was stated, the circlip located into the spring arm was bent and loose.The issue occurred before use on a patient and did not cause any injury or harm however we decided to report it in abundance of caution.Manufacturer reference number: (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The investigation has been finalized by manufacturing site, however the root cause needs to be confirmed.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light volista standop device.As it was stated, the circlip located into the spring arm was bent and loose.When the circlip is not fitted correctly the junction between the spring arm and the main arm is no longer ensured and that makes it possible to lead to cupola detachment.Regardless the fact that the issue occurred before actual use with a patient and did not cause any injury or harm we decided to report this event to competent authorities based on the potential and in abundance of caution.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.At the time when the event occurred the device was not being used for the patient treatment.During the investigation it was found that the occurrence rate for this issue of the circlip is low (1 complaint on volista surgical lights in the last 5 years of daily use of a large number of similar devices).The investigation was performed by maquet sas.The circlip involved in the event was returned and checked by maquet sas engineers and no default has been found.It was confirmed that the mechanical coupling between the spring arm and the main arm has failed because the circlip was not fully seated in its groove due to incorrect fitting at the installation or after spring arm exchange on-site.It is worth noticing that all instructions how to install or remove the spring arm in the surgical light are provided with the installation manual.The circlip needs to be checked immediately after assembly process according to the manual and, once the circlip is properly placed, it should be secured in place with a loctite-type industrial glue.We believe that overall these 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 and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4) exemption#: e2018005.Getinge usa sales, llc (b)(4).Contact person: (b)(6).

• Brand Name: VOLISTA STANDOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7237007
• MDR Text Key: 99608722
• Report Number: 9710055-2018-00007
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• 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: 06/14/2018

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: Health Professional
• Device Catalogue Number: 568803913
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 01/05/2018; 01/05/2018
• Supplement Dates FDA Received: 05/30/2018; 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1