MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LIGHT, SURGICAL, FLOOR STANDING

Device Problems Break (1069); Corroded (1131)

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

Event Date 05/21/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On (b)(6) maquet (b)(4) became aware of an incident with the surgical light device branded volista.It was stated that paint of the arm suspending the surgical light head was damaged showing signs of the corrosion.The issue appeared after 8 months in use from the installation.There was no information provided about the possible patient involvement and the circumstances of the discovery.The issue is being investigated.The follow up report will be provided upon conclusions from the investigation.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light volista device.It was stated that the arm suspending the surgical light head had damage marks on the paint and was showing signs of corrosion.The issue appeared after 8 months in use from the installation.There was no information obtained about the possible involvement of a patient, nor of the circumstances of the discovery.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the issue.The information about the time when the event occurred was not provided, we do not know if the device was or was not being used for the patient treatment.During the investigation it was found that to date the issue appears not to be a systematic problem, rather a single issue -and that the reported scenario has never lead, to date, to serious injury or worse.The problem has been in details consulted with the supplier, and from their feedback it appears there was an issue with their pre-painting preparation for this device.Therefore it seems that the most likely cause for the paint issue relates to this supplier of painted parts.Since then a new supplier provides the paintwork.In addition, the issue appears to have been compounded by suspension parts colliding during use.With regards to this facet we would like to point out that the user manual of the volista standop (standop volista user manual 01761en ed.07 page 65) includes information to daily check the light-head for chipped paint, impact marks and any other damage, we believe that this is a significant element that points out that if the user follows the manufacturers¿ recommendation available in the manual, the outcome would have been avoided.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• 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: 6649708
• MDR Text Key: 78034074
• Report Number: 9710055-2017-00043
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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