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

Model Number ARD568350933

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

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

On 9th january, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers were missing from spring arm.We decided to report the issue in abundance of caution as any parts 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 problem and h6 medical device ¿ problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 9th january, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers were missing from spring arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 9th january, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers were missing from spring arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that the dust covers were removed by technician in january when they were identified as damaged, and a new covers were installed during a service visit on july.The customer continued to use the device without dust covers until a new ones were installed.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as the dust covers were removed during service, and as to the best of our knowledge, under normal condition of use, a missing dust covers could not lead to any adverse event.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 corrected h6 medical device ¿ problem code: no apparent adverse event|||3189 initially provided information was pointing to missing of the dust covers.The issue was considered as safety related as any parts falling off into sterile field or during procedure may cause serious injury.Further information provided by getinge employee indicated that the dust covers were removed by technician in january when they were identified as damaged, and a new covers were installed during a service visit on july.The customer continued to use the device without dust covers until a new ones were installed.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as the dust covers were removed during service, and as to the best of our knowledge, under normal condition of use, a missing dust covers could not lead to any adverse event.Therefore, the scenario described in the record is considered as non-reportable.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 9th january, 2023 getinge became aware of an issue with one of surgical lights - powerled 500.It was stated the dust covers were missing from spring arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Further information provided by getinge employee indicated that the dust covers were removed by technician in january when they were identified as damaged, and a new covers were installed during a service visit on july.The customer continued to use the device without dust covers until a new ones were installed.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as the dust covers were removed during service, and as to the best of our knowledge, under normal condition of use, a missing dust covers could not lead to any adverse event.Therefore, the scenario described in the record is considered as non-reportable.

• 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: 17285473
• MDR Text Key: 318836493
• Report Number: 9710055-2023-00499
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 07/10/2023

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: ARD568350933
• Device Catalogue Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1