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

Model Number PRISMALIX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bruise/Contusion (1754)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2021 getinge became aware of an issue with prismalix surgical light.As it was stated, the surgical light fell down from ceiling.On (b)(6) 2021 therapeutic goods administration (tga) informed getinge about incident report received from the customer.In the report, the customer described the situation as follows: "surgical light assembly got dislodged from the mounting collar and fell down when the surgeon tried to move the light.Luckily missed the patient on the operating table, but bruised a caregiver.Later it was found that all six mounting bolts had got sheared on the mounting collar." there was no serious injury reported in regards to this particular incident, however we decided to report the issue based on the potential for the serious injury if the situation was to reoccur.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with prismalix surgical light.As it was stated, the surgical light fell down from ceiling.On 24th september 2021 (b)(6) informed getinge about incident report received from the customer.In the report, the customer described the situation as follows: "surgical light assembly got dislodged from the mounting collar and fell down when the surgeon tried to move the light.Luckily missed the patient on the operating table, but bruised a caregiver.Later it was found that all six mounting bolts had got sheared on the mounting collar." there was no serious injury reported in regards to this particular incident, however we decided to report the issue based on the potential for the serious injury if the situation was to reoccur.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification, since lamp fall could be considered as technical deficiency, and in this way device contributed to event.There is information that the device was not being used for patient treatment when the event took place.Following the information collected there is no evidence that the suspension fixing screws were checked or replaced during the previous maintenance.The failure of the screws is related to fatigue stresses due to moderate shear overload.All facies have a fatigue failure zone more or less extensive.Initiated at the bottom of the thread, the repeated low mechanical stresses caused the breakage of a first screw.The rupture of the other screws corresponds to progressive propagation of the shear effect.Since 2003, in order to prevent any incident, the yearly preventive maintenance program mentions to check the verticality and stability of lighting system.Manufacturer recommends prevent any incident the user manuals mentions that the yearly maintenance and inspection must be performed by a certified and trained technician.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: PRISMALIX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12553607
• MDR Text Key: 273998286
• Report Number: 9710055-2021-00316
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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 Model Number: PRISMALIX
• Device Catalogue Number: ARD567237998/ARD567236985
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/22/2021
• Patient Sequence Number: 1