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

Model Number ARD568350910

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 12/29/2023

Event Type  Injury  

Event Description

On 2nd january 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to serious injury of the patient and in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

Manufacturer Narrative

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

Event Description

On 2nd january 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, due to paint peeling from the fork and headlight detachment, which could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does indicate that upon the event occurrence, the device was being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of paint peeling on power-led and hled surgical lights, there is one event which led to the serious injury.Additionally, it was established and confirmed that the complaint at hand ((b)(4)) led to serious injury due to headlight detachment, which is also the first case of this kind registered for power-led and hled surgical lights.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the paint chipping is moderate and of the headlight detachment is very low.As stated by the subject matter expert at manufacturer¿s, a situation involving loose spring arm¿s safety sleeve is due to the loosening of the safety screw because of an incorrect initial tightening or a lack of inspection during the installation or the maintenance.To prevent the loosening and the absence of the screw, the installation manual (power-led installation manual 01584en08, pages 27-28) manual describes how to assemble the safety sleeve, the maintenance manual mentions to check for any loose covers and the service protocol included in this document mentions to check the presence of the spring arm¿s safety sleeve and the presence of the fixing screw (power-led maintenance manual, 01582en08, pages 17 and 255).The loosening and the absence of the safety sleeve screw can lead to the translation of the safety sleeve causing the fall of the light head (power-led installation manual 01584en09, pages 26-28).To prevent the risk of the separation of the light head, maquet dispatched the informative technical notice n.I.T.210 reminding the importance of the tightening control after installation or maintenance.A root cause analysis for paint peeling problem was performed by subject matter experts and concluded that all maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual (power-led¿s ifu 01581 rev.9, page 27) includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid collisions between devices (power-led¿s ifu 01581 rev.9, page 27).Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

On 2nd january 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.

Manufacturer Narrative

The purpose of this submission is to provide a correction of device references.The correction of b5 describe event or problem, d4 version or model #, d4 catalog #, d4 serial #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 2nd january 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 700.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Corrected b5 describe event or problem: on 2nd january 2024 getinge became aware of an issue with one of our surgical lights ¿ powerled 500.As it was stated, the headlight dislodged and fell off hitting the patient during preparation phase of the case.The safety ring screw was missing.According to initially provided information the patient was not seriously hit.As it was further clarified, the patient had a laceration on the forehead above the eyebrow which required stitches.The designated complaint unit employee confirmed based on photographic evidence additional issue of paint chipping from fork.We decided to report the issue due to the described outcome of the event, which constitutes a serious injury.Previous d4 version or model # ard568370926.Corrected d4 version or model # ard568350910.Previous d4 catalog # ard568370926.Corrected d4 catalog # ard568350910.Previous d4 serial # (b)(6).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.

• Brand Name: POWERLED
• 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: 18496910
• MDR Text Key: 332724288
• Report Number: 3013876692-2024-00003
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568350910
• Device Catalogue Number: ARD568350910
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2024
• Distributor Facility Aware Date: 04/18/2024
• Device Age: 14 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/26/2024; 04/18/2024
• Supplement Dates FDA Received: 01/30/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose