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

Catalog Number 568811911

Device Problem Crack (1135)

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

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights- volista standop.As it was stated, cracks have been found on the fork.The issue occurred before the operation however we decided to report the issue in abundance of caution.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005 getinge usa sales, llc (b)(6).Maquet sas became aware of an incident with a surgical light volista standop device.As it was stated, cracks have been found on the fork.The issue occurred before the operation however we decided to report the issue in abundance of caution.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.At the time when the event occurred the device was not 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 sas launched the capa 2015-03 and the design change request e160103 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.

• Brand Name: VOLISTA STANDOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7586464
• MDR Text Key: 111096676
• Report Number: 9710055-2018-00043
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 568811911
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1