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U.S. Department of Health and Human Services

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

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DRÄGERWERK AG & CO. KGAA POLARIS 100-200 LIGHT, SURGICAL Back to Search Results
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.
 
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Brand NamePOLARIS 100-200
Type of DeviceLIGHT, 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 Key12923051
MDR Text Key283145308
Report Number9611500-2021-00487
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 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 Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberG16980
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/03/2021 Patient Sequence Number: 1
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