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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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COOPERSURGICAL, INC. RUMI II; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number KC-RUMI-30
Device Problems Inflation Problem (1310); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2017
Event Type  malfunction  
Event Description
Surgeon was placing intrauterine tip in preparation for laparoscopic hysterectomy.Surgeon attempted to fill balloon for appropriate placement but balloon failed after filling less then 30ml saline and would not inflate.Placement of manipulator failed and a new tip was used.
 
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Brand Name
RUMI II
Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key6837481
MDR Text Key84326932
Report Number6837481
Device Sequence Number1
Product Code LKF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date04/30/2019
Device Model NumberKC-RUMI-30
Device Catalogue NumberKC-RUMI-30
Device Lot Number204941
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2017
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer08/29/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NONE RELATED TO THIS DEVICE
Patient Age44 YR
Patient Weight106
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