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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 Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Date 05/20/2021
Event Type  malfunction  
Event Description
The aveta hysteroscopy pump system malfunctioned during the procedure.The monitor blacked out.The disposable hysteroscope was replaced and the device functioned.This is a second occurrence, except with a different aveta pump system and different hysteroscope.Three hysteroscopes involved, see below: (1) aveta coral disposable hysteroscope ref# 214-251, lot# f21b05-01; (1) aveta coral disposable hysteroscope ref# 214-251.Lot# f21a06-01; (1) aveta coral disposable hysteroscope ref# 214-251.Lot# f21a06-01.
 
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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 Key11929561
MDR Text Key254027537
Report Number11929561
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 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number214-251
Device Catalogue Number214-251
Device Lot NumberF21A06-01, F21B05-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/25/2021
Event Location Hospital
Date Report to Manufacturer06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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