MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 600; LIGHTS

Catalog Number G16720

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

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

Event Date 11/09/2021

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 while using this reported polaris 600 for living donor liver transplantation, the handle of the polaris 600 fell into the clean field and then the glass and other items fell into the unclean field.No patient or staff injury was reported and no delay of the surgery.

Manufacturer Narrative

The investigation was based on the reported event, analysis of the provided photos and email correspondence.The affected polaris 600 with serial no.Askm-0416 was installed in march 2018 and the handle conversion mentioned was performed by dräger service in may 2018.Documentation on the handle adaptation was not available.The evaluation of the available information has shown that the reported fault scenario is due to an assembly error.This is also confirmed by the complainant.The assembly error occurred during a subsequent conversion (aka: retrofit) of the factory installed dräger multi-way handle handle "e" to the older dräger multi-way handle.Both dräger handle types differ in appearance and design.The customer wanted to standardize the handles.The polaris 600 installation manual explains each handle conversion step by step.In this context, the draeger complainant mentions that the retaining plate of the conversion kit was installed, but the factory-mounted retaining plate was incorrectly removed.The "design weakness" mentioned in the first complaint report is also due to the erroneous omission of the factory-mounted retaining plate during the conversion.Several fastening elements relevant to the complaint were missing.In response to queries, it is also not excluded that rough handling on the part of the user or a collision with neighboring surgical equipment may have contributed to the failure scenario at hand.In response to queries, it was clarified that the loose, fallen parts had fallen into the unclean area.The affected surgical procedure was able to be performed without significant interruption or harm to the patient.It is also not known whether the affected handle system was already loose/wobbly before it fell off.According to the associated instructions for use, the tight fit/security of the handle must also be checked before each use.When asked about this, the complainant states that the handle system in question was not checked accordingly before the operation in question.According to iec 60601-2-41 for the operation and safety of surgical lights, it is necessary to maintain a redundant light system, e.G., to ensure the uninterrupted completion of a surgical procedure without direct risk to the patient in the event of reduced function of one of the two lights.The instructions for use (ifu) also require the operator to clean and disinfect the light and arm system after each use to prevent infectious diseases.Furthermore, to prevent a patient hazard and to ensure operational readiness, it must be checked before each use whether the light system is free of visible damage.The respective light system is only ready for use if its proper inspection for operational readiness and reprocessing has been carried out without complaint in accordance with the hospital regulations and the ifu.Also, in accordance with the ifu, it is important to work carefully with the light system, as objects may otherwise fall into the operating field and cause personal injury and material damage.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 while using this reported polaris 600 for living donor liver transplantation, the handle of the polaris 600 fell into the clean field and then the glass and other items fell into the unclean field.No patient or staff injury was reported and no delay of the surgery.

• Brand Name: POLARIS 600
• Type of Device: LIGHTS
• 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: 12801974
• MDR Text Key: 283817746
• Report Number: 9611500-2021-00471
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G16720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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