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

Model Number VOLISTA 400

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On the 19th april maquet (b)(4) became aware of an incident with volista device.It was stated that the central support thread came out.The incident occurred during surgery but no one was injured.(b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light volista standop device.It was stated that central support thread came out and it is not getting fix again.Incident occurred during a surgery but nobody has injured.It was established that when the event occurred, the light-head did not meet its specification and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that the reported scenario has never lead to serious injury or worse.The root cause analysis confirmed that the malfunction of the central support can occur as a results of two factors: excessive tightening of screws during mounting of the handle support during installation or when the handle is removed and reinstalled at the customer site.To prevent any other similar incident we have addressed this issue with a field action msa-2017-006-iu in us market.

Event Description

Ref # (b)(4).

• Brand Name: VOLISTA STANDTOP
• 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: 6568929
• MDR Text Key: 75413485
• Report Number: 9710055-2017-00034
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VOLISTA 400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• 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