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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 72204878
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2024
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
According to the reporter, the device had a jagged edge.There was no patient involvement.
 
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Brand Name
TRUCLEAR
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN MANSFIELD
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN MANSFIELD
15 hampshire street
mansfield MA 02048
Manufacturer Contact
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key19137918
MDR Text Key341068196
Report Number1282497-2024-00054
Device Sequence Number1
Product Code HIH
UDI-Device Identifier10884521746633
UDI-Public10884521746633
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180496
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/18/2024
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 Health Professional
Device Model Number72204878
Device Catalogue Number72204878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Initial Date Manufacturer Received 03/22/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/26/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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