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

Model Number ARD567910910

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights.As it was stated, the oil leakage on the spring arm was noticed.There was no injury reported however we decided to report the issue in abundance of caution and based on the potential as any oil droplets falling off into sterile field or during procedure may lead to contamination.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with powerled surgical light.As it was stated oil dripping from the device was noticed.Oil drips from the hinge of the operating light onto the sterile field.There was no serious injury reported however we decided to report the issue in abundance of caution and based on the potential as any oil droplets falling off into sterile field or during procedure might cause a contamination.It was established that when the event occurred, the surgical light did not meet the manufacturers specification as although no technical malfunction has been found, the situation which occurred was not in accordance to device specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that there is no apparent trend in the complaints.A combination of air conditioning and excess of oil at the bushing location is the most probable root cause regarding this incident.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.

• 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: 9928627
• MDR Text Key: 189923053
• Report Number: 9710055-2020-00080
• 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,Followup
• Report Date: 07/22/2020

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: ARD567910910
• Device Catalogue Number: ARD567910910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 07/16/2020
• Supplement Dates FDA Received: 06/23/2020; 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1