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

Model Number STANDOP66DFDOUBLE

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician (fst)evaluated the device and found that the shaft between the cupola and the fork was broken.The investigation is-on-going and the results will be included in a follow-up report.The fst replaced the cupola by another one and returned the device to service.

Event Description

The customer reported that, the cupola was detached from the fork.There were no injuries reported.(b)(4).

Manufacturer Narrative

The field service technician replaced the cupola with a new one and returned the device to service.Maquet evaluated the broken cupola and determined that the device failed to meet its specification due to one missing fixing screw out of three.The screw was missing from production at the manufacturer facility.The investigation is ongoing and the result will be included in a follow-up report.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).A review of the working instruction in production was made and it requires to use three screws for this assembly.Therefore, it can be assessed that this is an isolated failure.A retraining of the operators in production was made in order to prevent similar events.

Event Description

Manufacturer reference # :(b)(4).

• Brand Name: VOLISTA
• 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: 6331720
• MDR Text Key: 67852732
• Report Number: 9710055-2017-00011
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K130513
• 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,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: STANDOP66DFDOUBLE
• Device Catalogue Number: STP229009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2015
• 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