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

Model Number ARD568811960

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista.As stated by technician, the problem with cracked fork and paint chip occurred.There is no patient injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.(b)(4).

Manufacturer Narrative

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)(4).Maquet sas became aware of an incident with a surgical light volista standop device.As stated by technician, the problem with cracked fork and paint chip occurred.There is no patient injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.We have no information when the event occurred and if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead to serious injury or worse, to death.The crack appears due to the detachment of the bonded parts and is only located on the outer coating.The cause of the coating damage corresponds to an excessive gap between both mechanical parts revealed before the coating manufacturing process.Maquet sas launched the capa 2015-03 and the design change request e160103 to improve the method for assembling the brackets replacing the bonding method by a welding process.The bracket assembled with the welding process is available since the beginning of 2017.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Manufacturer reference number: (b)(6).

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7747076
• MDR Text Key: 116394154
• Report Number: 9710055-2018-00063
• 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
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ARD568811960
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1