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

Catalog Number ARDVCS209006A

Device Problem Component Missing (2306)

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

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.(b)(4).

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of the surgical light- volista.As it was stated, the washers and circlips were missing in the suspension tube of the device.These parts are considered to be crucial for the device assembly.There was no injury reported, however we decided to report this issue as these missing parts, in the worst case scenario, could lead to the detachment of the device and cause an adverse event.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(.B)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc, 45 barbour pond drive, wayne, nj 07470.Contact person: (b)(6).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

On 14th january, 2019 maquet sas became aware of an issue with one of surgical lights- volista access.As it was stated, the washers and circlips were missing in the suspension tube of the device.These parts are considered to be crucial for the device assembly.There was no injury reported, however we decided to report this issue as these missing parts, in the worst case scenario, could lead to the detachment of the device and cause an adverse event.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 being used.The device has been recognized as volista access surgical light with serial number (b)(6).Defective part number is ardvcs209006a.The manufacturing date of the device is 6th september 2018.During the investigation it was found that this complaint is a second one received within last 5 years for a failure related with circlip being missing on the suspension arm.The investigation performed by the manufacturer concluded the root cause to be related with manufacturing error, namely operator omitting an assembly step indicated and described in the work instruction.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.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8286158
• MDR Text Key: 134722641
• Report Number: 9710055-2019-00032
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARDVCS209006A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other