MAUDE Adverse Event Report: MAQUET SAS VOLISTA; LAMP, SURGICAL

Catalog Number ARD568803933

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - volista.It was stated that camera keeps dropping out.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.

Event Description

On 2nd may, 2022 getinge became aware of an issue with one of surgical lights - volista.It was stated that camera keeps dropping out.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Then, on 5th july information provided by sme indicated that the issue is linked to the cs0052958 describing a loss of video signal.There is not mechanical trouble with device.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of falling parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.That is why it is not considered to be safety related and reportable.

Manufacturer Narrative

The correction of b5 describe event or problem deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 2nd may, 2022 getinge became aware of an issue with one of surgical lights - volista.It was stated that camera keeps dropping out.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 2nd may, 2022 getinge became aware of an issue with one of surgical lights - volista.It was stated that camera keeps dropping out.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Then, on 5th july information provided by sme indicated that the issue is linked to the cs0052958 describing a loss of video signal.There is not mechanical trouble with device.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of falling parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.That is why it is not considered to be safety related and reportable.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights ¿ volista access.It was stated that a "camera keeps dropping out".We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Then, on 5th july information provided by sme indicated that the issue is linked to the cs0052958 describing a loss of video signal.There is not mechanical trouble with device.Based on additional input from sme it was possible to determine that the issue investigated herein is not safety and risk related, as there was no indication of falling parts, which was initially considered.Therefore, the scenario described in the record is considered as non-reportable.It is not likely that the issue could lead to the serious injury or death when the malfunction reoccurs.That is why it is not considered to be safety related and reportable.According to the information provided by the getinge technician, the faulty camera was repaired and returned to the customer.Based on the information collected, it was established that the surgical light did not meet its specification, since a faulty camera could be considered a technical deficiency.As the issue was not considered safety-related, the device did not contribute to event.It is unknown if the claimed device was or was not being used for patient treatment or diagnosis when the issue occurred.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.According to the subject matter expert¿s evaluation, a recalibration of the sender dongle whdi was done by the supplier, he confirms that the camera was opened by someone (customer or service technician).Therefore, the issue is probably related to customer or technician fault.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of h6 medical device ¿ problem code field deems required.This is based on the internal evaluation.Previous h6 medical device ¿ problem code: mechanical problem|detachment of device or device component||2907.Corrected h6 medical device ¿ problem code: connection problem|loose or intermittent connection||1371.

• Brand Name: VOLISTA
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14314504
• MDR Text Key: 291221010
• Report Number: 9710055-2022-00145
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ARD568803933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1