MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 100/200 LIGHTS

Catalog Number G27600

Device Problem Contamination (1120)

Patient Problem Injury (2348)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during preparation of the operating theatre chips of the polaris painting fell into the sterile area. During a case chips were found inside the wound.

Manufacturer Narrative

As part of the root cause analysis, the affected surgical light body was examined. The reported paint flaking was confirmed. Furthermore, a visual change of the paint surface was detected, which indicates a chemical-mechanical effect. Further paint flaking could be produced in the laboratory. In comparison to a surgical light body from the current production, it was found that less force had to be applied to the defective surgical light to produce further paint flaking. Furthermore, the paint of the surgical light in question had a much more brittle structure. The disinfectant incidin extra n 0. 5% which was used according to the customer is not part of the disinfectants recommended in the instructions for use. For this reason, further compatibility tests were carried out in the laboratory in which this damage pattern could not be reproduced on a new light body. The wide distribution and conspicuous appearance of the existing paint flaking and visual paint changes on the defective light body indicate improper handling in the form of collisions with the surgical light body before, during or after surgery and excessive chemical-mechanical stress. Since a total of four surgical light bodies exhibit comparable paint defects of varying severity were found during inspection of the operating rooms, a systematic handling error can be assumed. Since, according to the warnings in the instructions for use, the collision of the lamp bodies and improper preparation must be avoided in order to prevent a possible patient hazard and equipment malfunction, the probability of paint particles falling into the sterile surgical field during an operation must be classified as improbable. The existence of lacquer defects does not impair the essential functionality of the surgical light. Furthermore, the instructions for use require an annual visual inspection to prevent potential malfunctions. Surgical lights must be cleaned and disinfected after each use. For this purpose, the instructions for use indicate suitable disinfectants and disinfection procedures which have been tested and approved for the lacquer structure of the surgical light body with regard to adhesive strength and chemical resistance.

Event Description

Please refer to the initial report.

• Brand Name: POLARIS 100/200
• Type of Device: LIGHTS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7446121
• MDR Text Key: 106008934
• Report Number: 9611500-2018-00114
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/01/2000
• Device Catalogue Number: G27600
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No