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

Model Number PWD700

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

On (b)(6) 2017 maquet sas became aware of an incident with powerled surgical light.As it was stated by the customer, the tube screws from suspension tube fixation have broken and come loose from the tube.(b)(4).

Manufacturer Narrative

¿maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4)¿.Maquet (b)(4) became aware of an incident with surgical light powerled device.As it was stated by the customer, the suspension tube fixation¿s tube screws have broken and have come loose from the tube.There was no patient involved.The malfunction occurred on powerled 700 device which is used to illuminate patients¿ bodies during operations, diagnosis or treatment.It was established that when the event occurred, the light-head did not meet its specification and it contributed to the event.At the time when event occurred the device was not used for patient treatment.During our investigation it was found that there is no apparent trend with the issue at hand and that the reported scenario has to date not lead to serious injury or worse.Furthermore it was found that an inappropriate tightening torque, a lack of threadlocker -loctite 243 and re-tightening over a period of several years are contributing factors leading to a progressive breakage of the screws.The involved screws were found without any signs of loctite on them.However, the powerled installation manual 01584en ed.04 on page 37 says that the fixing screws must be coated with medium strength threadlocker with reference number 606100243.Loctite 243, has a blue colour which is easy to detect.What is more, screws are instructed to be tighten by 5 mm allen key to a torque 14 nm (10.3 lb.Ft).We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would likely have been avoided.

Event Description

Manufacturer reference # : (b)(4).

• Brand Name: POWERLED 700
• 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: 6525451
• MDR Text Key: 74099763
• Report Number: 9710055-2017-00024
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD700
• Device Catalogue Number: 568370932
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other