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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDITRINA, INC. AVETA CORAL DISPOSABLE HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)
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MEDITRINA, INC. AVETA CORAL DISPOSABLE HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 214-251
Device Problems Device Difficult to Setup or Prepare (1487); Communication or Transmission Problem (2896); Compatibility Problem (2960)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Event Description
During the surgical procedure, a disposable hysteroscope would not function when plugged into the aveta system.The aveta system did not recognize the scope.The hysteroscope was plugged into both aveta machines without success.A replacement hysteroscope was recognized by the system and used for the case.The aveta representative was present for the procedure and assisted in troubleshooting the issue.The representative stated she would arrange for replacement of the malfunctioning hysteroscope.
 
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Brand Name
AVETA CORAL DISPOSABLE HYSTEROSCOPE
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
MEDITRINA, INC.
1190 saratoga ave, suite 180
san jose CA 95129
MDR Report Key12982959
MDR Text Key282105970
Report Number12982959
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number214-251
Device Catalogue Number214-251
Device Lot NumberF21D28-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/24/2021
Event Location Hospital
Date Report to Manufacturer12/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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