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

Catalog Number ARD568350952

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).The issue will be investigated by manufacturing site.

Event Description

On (b)(6) 2017 maquet (b)(4) became aware of an incident with one of surgical lights- hled.As it was stated, the light head fell off during surgery.There was no injury reported to patient and surgeon 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.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet (b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with a surgical light hled 500 device.As it was stated, the light head fell off during surgery.There was no injury reported to patient and surgeon however having in mind previous complaints of this nature we decided to report it to competent authorities based on the potential for serious injury if the issue was to reoccur.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the event.When the event occurred, the device was being used for the patient treatment.During the investigation it was found that the occurrence rate for the issue of the safety sleeve moving due to a missing screw is low (total of 3 complaints in the last 5 years of daily use of a large number of similar devices).Upon the performed investigation it was established that the event occurred as a combination of three different factors: a missing screw, the vertical motion of the safety sleeve and the transition of the safety segment.The screw that was missing should be noticed by the customer during annual device check that is recommended in the hled user manual 01601en ed.As there is information that all snap rings should be checked on all light heads.In the hled user manual 01601en ed.There is information that the device needs to be inspected by a maquet engineer or a trained technical support technician.The device involved in the event was 6 years old and did not have any evidence of performed preventive maintenance.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances and the fact that the occurrence rate is considered to be low we shall continue to monitor for any further events of this nature and do not propose any further action at this time.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).

Event Description

Manufacturer reference number (b)(4).

• Brand Name: HLED
• 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: 7112279
• MDR Text Key: 95463492
• Report Number: 9710055-2017-00078
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568350952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/17/2017; 11/17/2017
• Supplement Dates FDA Received: 03/21/2018; 04/05/2018
• 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