MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD568350931

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by the manufacturing site.

Event Description

On 25th september, 2017 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.As it was stated, the rubber bumper fell off during cleaning after the procedure.There is no injury reported however we decided to report the issue in abundance of caution.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).Maquet sas become aware of an incident with surgical light ¿ powerled.As stated by the customer the rubber bumper located at the bottom of the tube fell down.The event has been investigated.When the incident took place the device in the case at hand was not up to its specification and it contributed to the outcomes of the event.During the investigation it was found that there is a decreasing trend with the issue at hand and that the reported scenario has never lead to serious injury or worse, to date.As per performed tests the root cause of falling bumper is likely caused by repeated collisions with the cupolas, this can occur while the user is not being careful with moving the device arms and lights.The product user manual includes the information that the safety and integrity of the operation of the product are guaranteed only if all inspection, maintenance and repair operations are performed by a maquet engineer or an authorized technician.No injury occurred due to the reported event however we decided to report it in abundance of caution as it is improbable but possible that if this situation was to reoccur the patient, who was being treated when the malfunction occurred might be negatively impacted by the falling object.

Event Description

Reference number (b)(4).

• Brand Name: POWERLED 500
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 6964655
• MDR Text Key: 90757313
• Report Number: 9710055-2017-00066
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568350931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1