MAUDE Adverse Event Report: MAQUET SAS POWERLED II; LAMP, SURGICAL

Model Number ARDPWT259084A

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 Type  malfunction  

Manufacturer Narrative

Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On 2nd january, 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the hand holder fallen the to floor during cleaning.Designated complaint unit employee confirmed based on photographic evidence that handle was detached from device and some pieces from handle are broken off.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 or serious injury.

Event Description

On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the hand holder fallen the to floor during cleaning.Designated complaint unit employee confirmed based on photographic evidence that handle was detached from device and some pieces from handle are broken off.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 or serious injury.Further information provided by getinge employee indicated that the handle was removed during cleaning and falls on the floor from cleaners hand.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no detachment of handle during 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, h6 medical device ¿ problem code, h6 investigation findings, h6 component codes and h6 investigation conclusions deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the hand holder fallen the to floor during cleaning.Designated complaint unit employee confirmed based on photographic evidence that handle was detached from device and some pieces from handle are broken off.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 or serious injury.Corrected b5 describe event and problem: on (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the hand holder fallen the to floor during cleaning.Designated complaint unit employee confirmed based on photographic evidence that handle was detached from device and some pieces from handle are broken off.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 or serious injury.Further information provided by getinge employee indicated that the handle was removed during cleaning and falls on the floor from cleaners hand.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related, as there was no detachment of handle during use, 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 previous h6 investigation findings: results pending completion of investigation|||3233 corrected h6 investigation findings: no device problem found|||213 previous h6 medical device ¿ component codes: mechanical|handpiece||3067 corrected h6 medical device ¿ component codes: none previous h6 investigation conclusions: conclusion not yet available||11 corrected h6 investigation conclusions: no problem detected||67 initially provided information was pointing to handle detachment.The issue is considered as safety related as any parts falling off into sterile field or during procedure may cause contamination or serious injury.According to additional clarification provided by the getinge technician, the initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as the handle was removed during cleaning and falls on the floor from cleaners hand.The investigation was performed.The investigated scenarios did not cause risk to human life.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.It was established that when the event occurred, the device was up to the manufacturer specification and 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 II
• Type of Device: LAMP, SURGICAL
• 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: 18443716
• MDR Text Key: 331890375
• Report Number: 9710055-2024-00011
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDPWT259084A
• Device Catalogue Number: ARD569201967
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1