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

Catalog Number ARD569002999

Device Problems Unintended Arm Motion (1033); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4), (b)(4).This report relates to customer complaint registered with internal number (b)(4) that concerns the breakage of a surgical light spring arm.The spring arm failed in a way that allowed the surgical light to come down unexpectedly.The issue has been discovered by the in-house caretaker after use, therefore no patient was involved in this case.It was established that when the issue occurred, the light head did not meet its specification and it contributed to the complaint.In the time when the occurred the device was not being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported malfunction has never lead to serious injury or worse.It was reported that the weld at the front pivot of spring arm is broken.The breakage appears to have been caused by a tearing of the spring arm tube on the edge of the welding joint.The contributing factors are: excessive or repetitive mechanical stresses and intensive use.To prevent any other similar incident.This issue was previously addressed with a field action (in us: fda reference (b)(4)).This is possible because -as our investigation shows- the spring arm was not replaced as was required by the field action.We have found the root cause to be: human error.The german market service technician only performed a visual check of the spring arm welding but didn´t replace it, even although he was instructed to do so.As corrective action we reviewed the issue and found the involved service engineer was only responsible to conduct the remedial work in the one hospital involved here.Furthermore we have screened all local service reports which have been created within the field action.After this review we are convinced it is an issue that is limited to one single and very local human error.This employee has since been documented to have been retrained in ¿how to document the fulfilled service in the service report the right way¿.We report this event in all transparency since a malfunction occurred that did not cause an adverse outcome, but carried the potential.

Event Description

On (b)(4) 2017 maquet (b)(4) became aware of an incident with one of devices - hanaulux 2000.As it was stated, the spring arm failed in a way that allowed the surgical light to come down unexpectedly.The issue has been discovered by the in-house caretaker after the operation, therefore no patient was involved in this case.Manufacturer reference problem: (b)(4).

• Brand Name: HANAULUX
• 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: 6906804
• MDR Text Key: 88128556
• Report Number: 9710055-2017-00062
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K895715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD569002999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• 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: N
• Patient Sequence Number: 1