MAUDE Adverse Event Report: MAQUET SAS SW OPERATING LAMPS; HOLDER, CAMERA, SURGICAL

Model Number ARD567508999 - ACCESSORIES

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field.The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report this claim.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.There is correction of awareness date included in describe event or problem section.This is based on information provided in the complaint record.#b5: previous describe event or problem: on(b)(6)2019 getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field.The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report this claim.Corrected describe event or problem: on (b)(6)2019 getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field.The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report this claim.

Event Description

On (b)(6)2019 getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field.The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report this claim.

Manufacturer Narrative

Getinge was informed about complaint that during the operation, by using the camera a screw fell down into the operation field.The screw didn't fall on the patient, but in case of reoccurrence we find this situation as potential risk of contamination, so it was decided to report the received information.It was established that when the issue occurred, the device did not meet its specification and it contributed to the complaint as the screws are not to fall.In the time when the issue occurred the device was being used for patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand, in fact at this time the issue appears to be an isolated event despite many devices in the market and in constant use - 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.We believe that overall, the related devices are performing correctly in the market.

Event Description

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

• Brand Name: SW OPERATING LAMPS
• Type of Device: HOLDER, CAMERA, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9390366
• MDR Text Key: 178199999
• Report Number: 9710055-2019-00340
• 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
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567508999 - ACCESSORIES
• Device Catalogue Number: ARD567508999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1