MAUDE Adverse Event Report: MAQUET SAS X-RAY SHIELD MAVIG; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD567701907

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by the manufacturing site.

Event Description

On (b)(4) 2017 maquet (b)(4) became aware of an incident with x-ray mavig shield.The cover of the spring arm fell off.The circumstances of the event, the device involved brand name and patient involvement are not known however we decided to report this issue in abundance of caution.(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).Technician provided more information about the circumstances of the event.The issue occurred during cleaning and there was no injury reported.To repair the device, technician reinstalled the screws.

Event Description

Manufacturer reference number # (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The investigation has been finalized by manufacturing site, however the root cause needs to be confirmed.

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 x ray mavig spring arm.It was stated the spring arm cover fell off.Despite several attempts in gathering additional information, we were not able to establish the circumstances under which the issue was been discovered and what device was involved in the event.Therefore, we assumed that there is a possibility the issue could have occurred during an actual usage (worst case scenario) and decided to report it to competent authorities in abundance of caution and based on the potential, as any particle falling off the device during surgery might be a source of the contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.None of information available to date suggest that at the time when the event occurred the device was being used for the 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 x ray mavig 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.

Event Description

Manufacturer reference number # (b)(4).

• Brand Name: X-RAY SHIELD MAVIG
• 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: 7099849
• MDR Text Key: 95079309
• Report Number: 9710055-2017-00077
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/07/2018

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: ARD567701907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 11/29/2017; 11/29/2017; 11/29/2017; 11/29/2017; 11/29/2017
• Supplement Dates FDA Received: 03/21/2018; 05/23/2018; 06/14/2018; 07/12/2018; 08/07/2018
• 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