MAUDE Adverse Event Report: MAQUET SAS SATELITE; HOLDER, CAMERA, SURGICAL

Model Number ARD2SAT00131

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Issue is being investigated by manufacturer.Device not returned to manufacturer.

Event Description

On 13th march, 2020 getinge became aware of an issue with satellite device.As it was stated, screws were coming loose and were missing.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Getinge became aware of an issue with the screen holder, which is a part being in use with the surgical lights.The model of surgical light used was satelite device.As it was stated, screws were coming loose and were missing.There was no injury reported however we decided to report the issue based on the potential as any parts falling into the sterile field or during the procedure may cause a contamination.It was established that when the issue occurred, the device did not meet its specification as loose screws could be treated as technical deficiency and it contributed to the complaint as the screws shouldn't loosening.In the time when the issue 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.We conclude that the issue is most likely caused by wrong maintenance of the device.This defect is visually detectable during the inspection performed by the users before any surgical procedure.We believe the related devices are performing correctly in the market.

Event Description

Manufacturer's reference number: (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of additional manufacturer narrative/corrected data section.This is based on the result of an internal review.#h10: previous additional manufacturer narrative/corrected data: getinge became aware of an issue with the screen holder, which is a part being in use with the surgical lights.The model of surgical light used was satelite device.As it was stated, screws were coming loose and were missing.There was no injury reported however we decided to report the issue based on the potential as any parts falling into the sterile field or during the procedure may cause a contamination.It was established that when the issue occurred, the device did not meet its specification as loose screws could be treated as technical deficiency and it contributed to the complaint as the screws shouldn¿t loosening.In the time when the issue 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.We conclude that the issue is most likely caused by wrong maintenance of the device.This defect is visually detectable during the inspection performed by the users before any surgical procedure.We believe the related devices are performing correctly in the market.Corrected additional manufacturer narrative/corrected data: getinge became aware of an issue with the screen holder, which is an accessory to surgical lights.The model of surgical light assembly it was used with was a satelite device.As it was stated, screws were coming loose and were identified as missing.There was no injury reported however we decided to report the issue based on the potential as any parts falling into the sterile field or during the procedure may cause a contamination.It was established that when the issue occurred, the device did not meet its specification as loose screws could be treated as a technical deficiency and it contributed to the complaint as the screws shouldn¿t loosen.At the time when the issue 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 to our knowledge never lead to serious injury or worse.The loose screws are located on the mechanical connection between the screen support plate and the handle support.The picture of the device involved shows an improper mounting : the handle support is assembled behind the screen support plate, outside of the equipment.Increasing the torque on the mechanical connection.The handle support must be assembled between the screen and the screen support plate, close to the rotation point to reduce the torque.To prevent any incident the installation manual maquet equipment 01824 en 08 mentions the risk of equipment damage and explains how to install the handle in the correct direction.We conclude that the issue is most likely caused by wrong installation of the device.We believe the related devices are performing correctly in the market.

• Brand Name: SATELITE
• Type of Device: HOLDER, CAMERA, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9915711
• MDR Text Key: 187922284
• Report Number: 9710055-2020-00074
• Device Sequence Number: 1
• Product Code: FXR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD2SAT00131
• Device Catalogue Number: ARD2SAT00131
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1