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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)
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COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number 72204064
Medical Device Problem Codes Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/16/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during hysteroscopy myomectomy, the device was functioning properly then just stalled and stopped working.The procedure was aborted.
 
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Brand Name
TRUCLEAR
Common Device Name
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MANSFIELD
15 hampshire street
mansfield MA 02048
MDR Report Key10235367
Report Number1282497-2020-00020
Device Sequence Number18981271
Product Code HIH
UDI-Device Identifier10884521744097
UDI-Public10884521744097
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K161763
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/03/2018
Device Model Number72204064
Device Catalogue Number72204064
Device Lot Number72204064
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/16/2020
Initial Report FDA Received Date07/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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