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

Model Number VLT64DFSTP

Device Problems Detachment Of Device Component (1104); Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician evaluated the device and found that the spring arm is rusted.The investigation is on-going and the result will be included in a follow-up report.

Event Description

While maquet field service technician was performing a routine maintenance on a surgical light he found that the spring arm was rusted and some particles fell off.There were no injuries reported.(b)(4).

Manufacturer Narrative

Maquet evaluated the device and determined that the device failed to meet its specification due to a poor painting process.Investigations were conducted at the suppliers' and maquet was able to verify that the painting process is validated and therefore concludes to an isolated error at the suppliers' on this particular unit.Additionally the device is directly involved with the reported incident and however was not being used for treatment or diagnosis on patient when the event occurred.The volista series operating manual indicates that users should "check the system for impact marks and other surface damage" on a daily basis.

Event Description

Factory reference number: (b)(4).

• Brand Name: VOLISTA STANDOP
• 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: 5999457
• MDR Text Key: 57251526
• Report Number: 9710055-2016-00087
• 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
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLT64DFSTP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1