MAUDE Adverse Event Report: FREDERIC LELEU - MAQUET SAS POWERLED 300; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 568330933

Device Problem Unintended Arm Motion (1033)

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

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On the (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled 300.As it was stated by the customer, the cover of the spring arm fell down and made a contact with the patient.There is no injury reported.(b)(4).

Manufacturer Narrative

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

Event Description

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).

Manufacturer Narrative

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

Event Description

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).

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

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).

Manufacturer Narrative

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

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 powerled device.As it was stated by the customer, the cover of the spring arm fell down and made a contact with the patient.Fortunately, there was no adverse outcome reported.The case occurred during preparation before the surgery (laparotomy).After the issue occurrence, the surgery was started without any delay or additional problems.The surgery was finished successfully.According to the information provided by nurse, the spring arm might have been hit t during the previous surgery, thus it was dislocated and fell from the device.The technician, who visited the site, was able to repair the device by attaching a new cover and the device was returned to use.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the incident.In the time when the event occurred the device was being used for patient treatment.During the investigation it was found that this event is the first case reported to getinge regarding detachment of the cover on the powerled in the last 5 years.The reported scenario for the same has never led 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 during installation on-site 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.We believe that if the manufacturer recommendation 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.

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 sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc, 45 barbour pond drive, wayne, nj 07470.

Event Description

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 sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Manufacturer reference number: (b)(6).

• Brand Name: POWERLED 300
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• MDR Report Key: 7651062
• MDR Text Key: 113015714
• Report Number: 9710055-2018-00052
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 568330933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1