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

Model Number ARD568370903

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

Event site name: (b)(6).Event site telephone: (b)(6).Initial reporter was getinge technician additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 30th november, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.Designated complaint unit employee confirmed based on photographic evidence the screws that secure transparent plastic cover were missing, also the paint was peeling from headlight and there was paint damage on fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.

Event Description

On 30th november, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.Designated complaint unit employee confirmed based on photographic evidence the screws that secure transparent plastic cover were missing, also the paint was peeling from headlight and there was paint damage on fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that the paint wasn't peeling from device, it was a dent in the paint, also that screws were removed during service visit by getinge technician.Based on that additional input it was possible to determine that the issues investigated herein are not safety and risk related, as there was no indication of missing particles during daily use, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.

Manufacturer Narrative

The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 30th november, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.Designated complaint unit employee confirmed based on photographic evidence the screws that secure transparent plastic cover were missing, also the paint was peeling from headlight and there was paint damage on fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 30th november, 2023 getinge became aware of an issue with one of surgical lights - powerled 700.Designated complaint unit employee confirmed based on photographic evidence the screws that secure transparent plastic cover were missing, also the paint was peeling from headlight and there was paint damage on fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee indicated that the paint wasn't peeling from device, it was a dent in the paint, also that screws were removed during service visit by getinge technician.Based on that additional input it was possible to determine that the issues investigated herein are not safety and risk related, as there was no indication of missing particles during daily use, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|degraded|peeled/delaminated|1454 mechanical problem|detachment of device or device component||2907 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 initially provided information was pointing to paint peeling and missing screws.These issues are considered as safety related as any parts or particles falling off into sterile field or during procedure may cause contamination.According to additional information provided by the getinge technician, the initial information was not clear.It was determined that the issues investigated herein are not safety and risk related as there was no indication of missing particles during daily use.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.

• 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: 18289317
• MDR Text Key: 330133405
• Report Number: 9710055-2023-00943
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/08/2023

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: ARD568370903
• Device Catalogue Number: ARD568370903
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1