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

Model Number ARD568811960

Device Problems Crack (1135); Material Fragmentation (1261)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet (b)(4) 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 (b)(4) launched the capa (b)(4) and the design change request (b)(4) 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

On 18th july, 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista.The fork has a crack and a paint chipping occurred in this place.There is no 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).

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 7789466
• MDR Text Key: 117608535
• Report Number: 9710055-2018-00067
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568811960
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1