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

Model Number ARD568370935

Device Problems Crack (1135); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (b)(6).Event site name: (b)(6).Event site city: (b)(6).2-11-3.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 6th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the bumper on the horizontal arm was partially cracked.Photographic evidence confirmed that issue and indicated that due the crack there was a risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

The correction of b5 describe event and problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 6th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the bumper on the horizontal arm was partially cracked.Photographic evidence confirmed that issue and indicated that due the crack there was a risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 6th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the bumper on the horizontal arm was partially cracked.Photographic evidence confirmed that issue and indicated that due the crack there was a risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that no particles were missing from the device.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Material integrity problem|crack||1135.Corrected h6 medical device ¿ problem code: no apparent adverse event|||3189.Initially provided information was pointing to the bumper on the horizontal arm which was partially cracked with risk of missing particles.The issue is considered as safety related as any particles particles falling off into sterile field or during procedure may cause contamination or serious injury.According to additional information provided by the getinge technician, the initial information was not clear.It was determined that the issue investigated herein is not safety and risk related as there was no indication of missing particles.Therefore, the scenario described in the record is considered as non-reportable.It was established that when the event occurred, the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On 6th december, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the bumper on the horizontal arm was partially cracked.Photographic evidence confirmed that issue and indicated that due the crack there was a risk of missing particles.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that no particles were missing from the device.Based on that additional input it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of missing particles, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: POWERLED 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: 18318684
• MDR Text Key: 330384673
• Report Number: 9710055-2023-00955
• Device Sequence Number: 1
• Product Code: FSY
• 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,Followup
• Report Date: 12/13/2023

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 Model Number: ARD568370935
• Device Catalogue Number: ARD568370935
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1