MAUDE Adverse Event Report: MAQUET SAS G8E; LIGHT, SURGICAL, CEILING MOUNTED

Device Problems Component Falling (1105); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).A follow-up medwatch will be submitted when additional information is received.

Event Description

On (b)(6) 2017 maquet (b)(4) became aware of incident with one of devices-- surgical light g8 evolution.It was stated that during surgery arms got hit each other and the cover of one of spring arm fell off.No adverse effect on the patient was reported however we decided to report this issue in abundance of caution.Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (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, (b)(4).Maquet sas became aware of an incident with surgical light g8 evolution device.It was stated that during surgery two spring arms hit each other and the cover of one of them fell down.The cover did not fall in the operating field and the surgery could be completed, there was no injury or contamination reported.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the event.At the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that this is a single, isolated case and that the reported scenario has never lead to serious injury or worse.The manufacturer has performed an investigation for that case.According to the results of the investigation there are two factors that could cause a fall of plastic cover.Potential root causes of the fall might be due to an incorrect attachment of the dust cover or a detachment might happened due to repeated collisions.Collisions could occur during handling of the device, however they are considered as an inappropriate use of the device by user.The operating manual includes the instructions to pre-position the arms prior to use in order to prevent damages.To prevent any other similar case, maquet sas recommends in g8 evolution user manual 0138101 nu en es ed.1g how to properly position the surgical light before the procedure.We believe that if the manufacturer recommendation in the ifu would have been followed the incident would have been avoided.Given the circumstances and the fact that this complaint is considered to be a single, isolated event we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: G8E
• 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: 6852915
• MDR Text Key: 85763833
• Report Number: 9710055-2017-00059
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• 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?: Yes
• Date Manufacturer Received: 08/15/2017
• 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: Reuse
• Patient Sequence Number: 1