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

Model Number VLT400DFTKAIMSTP

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician (fst) evaluated the device and found some cracks on the plastic sterilizable handle support, indicating that the three holding pins got torn out while the light was manipulated.The damaged handle assembly was replaced with a new one and the device returned to service.Maquet determined that the event was caused by an excessive mechanical effort that stressed the handle support during use.The volista user manual instructs users to check the lighthead for any damage, on a daily basis.

Event Description

The customer reported that the handle assembly is not holding on and comes off easily from the central support, with components falling off.No injuries were reported.(b)(4).

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): MAQUET SAS; orléans cedex 2 ; FR

orléans cedex 2 

• MDR Report Key: 5551488
• MDR Text Key: 42533365
• Report Number: 9710055-2016-00024
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLT400DFTKAIMSTP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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