MAUDE Adverse Event Report: HANAULUX; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number HM58000540

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 25th december, 2020 getinge became aware of an issue with one of surgical lights.As it was stated by the customer, the oil leakage on the spring arm was noticed.There was no injury reported however we decided to report the issue and based on the potential as any oil droplets falling off into sterile field or during procedure may lead to contamination.

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - hanaulux.As it was stated by the customer, some droplets of oily substance leakage on the spring arm appears to have been noticed.There was no injury reported however, we decided to report the issue and based on the potential as any unsterile droplets falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information if upon the event occurrence, the device was or was not being used for patient treatment.During the investigation, it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Unfortunately, manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.

Event Description

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

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

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

• Brand Name: HANAULUX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 11093838
• MDR Text Key: 224433151
• Report Number: 9710055-2020-00525
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: HM58000540
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1