MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2000; LAMP, SURGICAL

Model Number HM56076869

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Event site city: (b)(6).Event site name: (b)(6).Event site postal code (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 20th november, 2023 getinge became aware of an issue with one of surgical lights - hanaulux 2000.It was stated that the handle of the headlight (focus axis exchanger) broke and fell off.The technician indicated that there was no patient harm as issue was discovered during daily check.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination in case of event reoccurrence.

• Brand Name: HANAULUX 2000
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18238796
• MDR Text Key: 329385674
• Report Number: 9710055-2023-00928
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HM56076869
• Device Catalogue Number: HM56076869
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1