MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL

Model Number ARDLCA109005A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 23rd august, 2021 getinge became aware of an issue with one of surgical lights - lucea 100.The criclip of sterilizable handle holder was missing.There was no injury reported, however, we decided to report the issue in abundance of caution, as parts or particles falling off into sterile field or during procedure may cause hazardous situation.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - lucea 100.The circlip of sterilizable handle holder was missing.There was no injury reported, however, we decided to report the issue in abundance of caution, as parts or particles falling off into sterile field or during procedure may cause hazardous situation.It was established that when the issue occurred, the device did not meet its specification (since the circlip was missing) and it contributed to the event.At the time when the issue was noticed the device was not being used for patient treatment.Two possible causes have been identified, but the breakage of the circlip because of oxidation is the most probable root cause.The curative and preventive action plan n° 2015-06 has been initiated to identify the reason of this oxidation.Then, it has been decided to improve the current circlip material stainless steel a2 by stainless steel a4 more resistant to chemicals.The 2 test batches sent in brazil and germany and the salt spray tests made in laboratory prove that circlips made in stainless steel a4 solve the oxidation troubles.According to this result, the modification has been applied in our production line since 9th november, 2017.The correction of catalog# field deem required.This is based on the internal evaluation.#d4: previous catalog #: ardlca109005a corrected catalog#: ard568603999.

• Brand Name: LUCEA 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12370343
• MDR Text Key: 268232419
• Report Number: 9710055-2021-00293
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA109005A
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1