MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2005; LAMP, SURGICAL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - hanaulux 2005.As it was stated, the set pin of handle pillar came off and fell down into sterile field during procedure.There was no injury reported however we decided to report the issue in abundance of caution as any broken parts falling off into sterile field or during procedure might cause contamination.

Manufacturer Narrative

Getinge became aware of an incident with hanaulux surgical light.As it was stated set pin of handle pillar mounted on the device came off and fell down into sterile field during a surgery.Fortunately, there was no adverse outcome reported however, we decided to report the issue based on the potential for injury if the situation was to reoccur, as any object falling into the sterile field might be a source of cross contamination.It was established that when the event occurred, the surgical light did not meet its specification and was directly involved in the reported event.When the issue occurred it was being used for patient treatment.When reviewing similar reportable events for the same device, we have been able to confirm that prior to this event none were reported to getinge company, this is considered as single isolated event.Despite the effort made the involved part of the device could not be returned for further investigation as was disposed by the customer.Therefore detailed investigation could not be performed.The manufacturer¿s subject matter experts have reviewed the information provided including photographic evidence and unfortunately could not provide the specific root cause which was not possible to be established.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: HANAULUX 2005
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10475842
• MDR Text Key: 207589619
• Report Number: 9710055-2020-00341
• Device Sequence Number: 1
• Product Code: FTD
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1