MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568350958

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 Type  malfunction  

Event Description

On 4th october, 2023 getinge became aware of an issue with one of surgical lights - hled.It was stated the handle holder detached from the arms and the 2 screws that held the holder were stuck in the device.Moreover, the paint was chipping from the monitor arms.All the issues were confirmed by photographic evidence.We decided to report the issues in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

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

Manufacturer Narrative

The correction of b5 describe event and d1 brand name and d2a product code for the fda and d2b common device name and d4 catalog # and d4 serial # deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 4th october, 2023 getinge became aware of an issue with one of surgical lights - held.It was stated the handle holder detached from the arms and the 2 screws that held the holder were stuck in the device.Moreover, the paint was chipping from the monitor arms.All the issues were confirmed by photographic evidence.We decided to report the issues in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 4th october, 2023 getinge became aware of an issue with one of surgical equipment - xd dual flat screen (24) holder.It was stated the handle holder detached from the arms and the 2 screws that held the holder were stuck in the device.Moreover, the paint was chipping from the monitor arms.All the issues were confirmed by photographic evidence.We decided to report the issues in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.Previous d1 brand name: hled corrected d1 brand name: xd dual flat screen (24) holder previous d2a product code for the fda: fsy corrected d2a product code for the fda: fxr previous d2b common device name: light, surgical, ceiling mounted corrected d2b common device name: holder, camera, surgical previous d4 catalog # ard568350958 corrected d4 catalog # ard567701940 previous d4 serial # (b)(6) corrected d4 serial # (b)(6).

Event Description

On 4th october, 2023 getinge became aware of an issue with one of surgical equipment - xd dual flat screen (24) holder.It was stated the handle holder detached from the arms and the 2 screws that held the holder were stuck in the device.Moreover, the paint was chipping from the monitor arms.All the issues were confirmed by photographic evidence.We decided to report the issues in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.

• Brand Name: HLED
• 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: 17951267
• MDR Text Key: 326046628
• Report Number: 9710055-2023-00768
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/17/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568350958
• Device Catalogue Number: ARD568350958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1