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

Model Number ARD2STP00120AG

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

On 6th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.Based on photographic evidence label and paint were damaged with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Event site name: (b)(6) additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The correction of b5 describe event and problem and h6 medical device - problem code deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 6th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.Based on photographic evidence label and paint were damaged with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 6th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.Based on photographic evidence the label and paint appeared to have been damaged with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee on 1st december stated that there was no missing particles, paint and label were in good condition.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device - problem code: material integrity problem|degraded|peeled/delaminated|1454 and mechanical problem|detachment of device or device component||2907 corrected h6 medical device - problem code: no apparent adverse event|||3189.It was established that when the event occurred the device was not being used for patient treatment or diagnosis.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

Event Description

On 6th november, 2023 getinge became aware of an issue with one of surgical lights - volista standop.Based on photographic evidence the label and paint appeared to have been damaged with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Further information provided by getinge employee stated that there was no missing particles, paint and label were in good condition.Based on additional input from getinge employee it was possible to determine that the issue investigated herein is not safety and risk related.Therefore, the scenario described in the record is considered as non-reportable.

• Brand Name: VOLISTA STANDOP
• 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: 18147936
• MDR Text Key: 328267073
• Report Number: 9710055-2023-00887
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD2STP00120AG
• Device Catalogue Number: 515072999/567910994/515073999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1