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

Device Problem Crack (1135)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

We are aware that this is past the 30 day deadline for reporting.The service unit forwarded the information late due to error in submission.The issue is being investigated by manufacturing site.(b)(4).

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista.As it was stated, the racket of the surgical light is cracked.There was no injury reported however we decided to report the issue in abundance of caution as the crack in the racket may lead to detachment of the light head and this may lead to an adverse event.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

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

Event Description

Manufacturer's 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 (b)(4).Contact person: (b)(6).

Event Description

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

Manufacturer Narrative

On (b)(6)2018 getinge bedame aware of an issue with surgical light volista, related to a cracked bracket.The device has been recognized as volista 400 standop device with serial numer (b)(4).Defective part numer is 568812960.The product was manufactured (b)(6)2015.The dhr was reviewed and no anomaly was found.The investigation was performed by product specialists at the manufacturer.It was established that the root cause of this incident is that one of three screws and its lock washer is missing.The lack of marks on metal at screw location is seen as concrete evidence of that fact.This screw has likely been forgotten on the assembly line during manufacturing proces.The control proces has been reinforced since january, 2016 and the check of the presence of these 3 screws is now required.To sum up, the issue occurence is due to manufacturing error.It was established that when the event occured, the surgical light did not meet its specification and it contributed to event.During the investigation it was found that the occurance rate for the issue of the bracket bearing is low (total of 15 complaints in the last 5 years of daily use of a large numer of similar devices).The affected devices are now being updated during field safety corrective action msa-2018-001-iu.The device involved in the event was found to be in scope of mentioned fsca and action was performed after reported issue, therefore getinge does not propose any other action at this time.

Event Description

Manufacturer's reference number 2018-60826.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8362187
• MDR Text Key: 138144801
• Report Number: 9710055-2019-00043
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other