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

Model Number PWD500DFK3

Device Problems Break (1069); Split (2537)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer evaluated the device and found that the circlip of the handle support clip is broken in two parts.The customer replaced the handle support with a new one and returned the device to service.The investigation is ongoing and the results will be included in a follow up report.

Event Description

The customer reported that, during a surgery, the handle support clip was broken into two parts.There were no injuries reported.(b)(4).

Manufacturer Narrative

Maquet evaluated the device and determined that the device failed to meet its specification due to corroded clip which caused the breakage.Additionally, the device was directly involved with the reported incident and was being used for treatment on the patient when the event occurred.As part of the investigation, maquet performed some tests in order to attempt to reproduce the failure, and create corrosion.Two handle supports out of the internal stock (both equipped with a clip) were dived into 2 aggressive and over concentrated cleaning products.After one month of diving/drying cycles, maquet was not able to create corrosion on the 2 clips.Maquet power led series operating manual indicated that the users should "check he sterilisable handle clicks and locks in place correctly" on a daily basis.

Event Description

Manufacturer reference # :(b)(4).

• Brand Name: POWERLED
• 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: 6292829
• MDR Text Key: 66511799
• Report Number: 9710055-2017-00008
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PWD500DFK3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• 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