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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVUITY, INC. EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER; LIGHT, SURGICAL, CARRIER
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INVUITY, INC. EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER; LIGHT, SURGICAL, CARRIER Back to Search Results
Model Number NARROW / FLAT
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Superficial (First Degree) Burn (2685)
Event Date 02/12/2020
Event Type  malfunction  
Event Description
Surgeon was using eikon light with photonglide narrow/flat adapter piece.After turning the light source on during surgery, the adapter piece malfunctioned and burned the surgeon's hand.The surgeon de-gowned and removed his gloves but declined any further medical assistance for the burn.It was deemed appropriate to replace the aforementioned light adapter.The surgeon scrubbed back into the case, as sterility was maintained throughout the incident.The malfunctioning piece was examined by the circulator and certified surgical technologist (cst), then given to the circulator's clinical manager for further investigation/follow up with the manufacturer.
 
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Brand Name
EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER
Type of Device
LIGHT, SURGICAL, CARRIER
Manufacturer (Section D)
INVUITY, INC.
444 de haro st
san francisco CA 94107
MDR Report Key12016315
MDR Text Key256723813
Report Number12016315
Device Sequence Number1
Product Code FSZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNARROW / FLAT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2021
Event Location Hospital
Date Report to Manufacturer06/17/2021
Type of Device Usage Unknown
Patient Sequence Number1
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