MAUDE Adverse Event Report: MAQUET SAS POWERLED 500/700; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568350908

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

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

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text: device not returned to manufacturer.

Event Description

On 12th september, 2023 getinge became aware of an issue with one of surgical lights - configuration of powerled 500 and 700.It was stated the circlip attaching the spring arm and bushing to the suspension arm had come loose, the spring arm had come loose but was held in place by friction due to its weight and the connection cable.Moreover, based on photographic evidence the paint was chipping from fork, suspension arm and main tube and the labels were chipping from fork, spring arm and suspension arm.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection of arms could lead to detachment of the spring arm and as a result of that, could lead to serious injury and any particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: POWERLED 500/700
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 17797451
• MDR Text Key: 324012387
• Report Number: 9710055-2023-00720
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2023

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: ARD568350908
• Device Catalogue Number: ARD568350908
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1