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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATHETER RESEARCH, INC./THOMAS MEDICAL INC.; CANNULA, MANIPULATOR/INJECTOR, UTERINE

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CATHETER RESEARCH, INC./THOMAS MEDICAL INC.; CANNULA, MANIPULATOR/INJECTOR, UTERINE Back to Search Results
Model Number TMI1151
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2017
Event Type  malfunction  
Event Description
During a laparoscopy procedure, an approximately 1-inch plastic tip of a disposable uterine manipulator broke off in a patient's cervix while in use by the proceduralist.
 
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Type of Device
CANNULA, MANIPULATOR/INJECTOR, UTERINE
Manufacturer (Section D)
CATHETER RESEARCH, INC./THOMAS MEDICAL INC.
6102 victory way
indianapolis IN 46278
MDR Report Key6857845
MDR Text Key85802890
Report Number6857845
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 08/01/2017,08/22/2017
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 Other
Device Expiration Date02/01/2021
Device Model NumberTMI1151
Device Catalogue NumberTMI1151
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/01/2017
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer08/01/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/12/2017
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
NO OTHER THERAPIES; NO, ONLY A TENACULUM ON THE ANTERIOR LIP OF CERVIX
Patient Age31 YR
Patient Weight48
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