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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 72203012
Medical Device Problem Codes Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/26/2020
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 a procedure, the product did not perform its reciprocating function to be able to make a recession of the intra-uterine myoma.No other instrument was use and the product was removed from the hand piece.The case was aborted, and was rescheduled on (b)(6) 2020.
 
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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 Key10696888
Report Number1282497-2020-00042
Device Sequence Number3282153
Product Code HIH
UDI-Device Identifier00885554027617
UDI-Public00885554027617
Combination Product (Y/N)N
Initial Reporter CountryRQ
PMA/510(K) Number
K130215
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/19/2020
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 Date12/20/2020
Device Model Number72203012
Device Catalogue Number72203012
Device Lot Number4067716
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/19/2020
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;
Patient Age40 YR
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