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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA POLARIS 100/200 LIGHTS Back to Search Results
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.
 
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Brand NamePOLARIS 100/200
Type of DeviceLIGHTS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
MDR Report Key7446121
MDR Text Key106008934
Report Number9611500-2018-00114
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
PMA/PMN Number
K123776
Number of Events Reported1
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 Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Device Catalogue NumberG27600
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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