MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 100-200; LIGHT, SURGICAL

Catalog Number G16980

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Pain (1994)

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that during a surgical procedure, a surgical light polaris 100-200 had a heavier movement than usual and when positioning it close to the patient, the cupola (polaris) came to detach from the stand and fall on top of the patient's leg.It was reported that the patient was recovering well.The user complaint of wrist pain.No serious injury occured.

Manufacturer Narrative

The investigation was based on the assessment of available information including pictures of the affected device.The affected device itself was not made available for investigation at the manufacturer¿s site neither was it possible for the dräger service to examine the failure pattern onsite.Only a visual inspection of the already reassembled device could be carried out.The installation date of the affected or light is not known; neither were installation protocols or maintenance records available.As reported the or lights of the hospital are repaired and maintenance by a 3rd party company (no dräger service).Based on the available information it could be verified that the mechanical connection between the or light head and the cardanic holder disconnected causing the or light to fall off the holder.One of the provided pictures shows, that the retaining ring, which is responsible for the mechanical connection between the cardanic pin and the cardanic holder, had come loose from its retaining groove.Based on the available information it could not be finally clarified why this had happened.The onsite inspection of the affected device by dräger service, however, showed evidence of various technical interventions on the affected or light, such as scratch and abrasion marks on the coverings, screw-in attempts in the wrong places and an outdated maintenance date (time target for next maintenance: 04/2020) on a label on the associated central axis.The investigation therefore concluded that a mounting failure e.G.As part of a 3rd party service measure must have caused the event.A design failure and/or a manufacturing failure of the or light could be excluded; and also, rough handlings was considered very unlikely due to the specific failure pattern.In accordance with the instructions for use, the operational readiness of the system, including the visual inspection for damage, must be checked before each use.All nine onsite installed or lights have been preventatively checked by visual inspection without deviations.It was recommended the user commissions dräger service for maintenance and repair.There are no comparable events known; the current event was therefore evaluated as single case.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that during a surgical procedure, a surgical light polaris 100-200 had a heavier movement than usual and when positioning it close to the patient, the cupola (polaris) came to detach from the stand and fall on top of the patient's leg.It was reported that the patient was recovering well.The user complaint of wrist pain.No serious injury occured.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that during a surgical procedure, a surgical light polaris 100-200 had a heavier movement than usual and when positioning it close to the patient, the cupola (polaris) came to detach from the stand and fall on top of the patient's leg.It was reported that the patient was recovering well.The user complaint of wrist pain.No serious injury occured.

• Brand Name: POLARIS 100-200
• Type of Device: LIGHT, SURGICAL
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12923051
• MDR Text Key: 283145308
• Report Number: 9611500-2021-00487
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• PMA/PMN Number: K123776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G16980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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
• Patient Outcome(s): Required Intervention