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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED SCINTILLANT SURGICAL LIGHT

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ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED SCINTILLANT SURGICAL LIGHT Back to Search Results
Model Number 2762-01-0004
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
The light was requested to be returned. Pictures and additional information was also requested. Investigation is pending until more information can be received. Report was not submitted within the 30 day deadline due to technical challenges with webtrader.
 
Event Description
It was reported that the lens of the surgical light broke off. There was no patient involved with the event.
 
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Brand NameSCINTILLANT SURGICAL LIGHT
Type of DeviceSURGICAL LIGHT
Manufacturer (Section D)
ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED
85 industrial drive
phillipsburg NJ 08865
Manufacturer Contact
eric tarnowski
85 industrial dr.
phillipsburg, NJ 08865
9083299123
MDR Report Key12260056
MDR Text Key266605270
Report Number3005977121-2021-00001
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2762-01-0004
Device Catalogue Number2762-01-0004
Device Lot Number11211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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