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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
Device Problems Fail-Safe Problem (2936); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/13/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an operative hysteroscopy, hysteroscopic myomectomy procedure, the blade of the device would not move when window lock pressed on footswitch.Window lock did not function and test blade ran at exceedingly fast speeds.The patient was unable to be treated and was rescheduled.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an operative hysteroscopy, hysteroscopic myomectomy procedure, the blade of the device would not move when window lock pressed on footswitch.Window lock did not function and test blade ran at exceedingly fast speeds.The patient was unable to be treated and was rescheduled.
 
Manufacturer Narrative
Additional information: g3, h6 information received shows that this event is a duplicate of another issue reported under regulatory report # 1282497-2022-00044.This file will be closed and all further updates processed under the above-referenced report for this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: b5, g3, h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during an operative hysteroscopy, hysteroscopic myomectomy procedure, the blade of the device would not m ove and becomes jammed when window lock pressed on footswitch.They were using an 8mm scope and dense tissue shaver plus when the handpiece/blade failed to rotate.Window lock did not function and test blade ran at exceedingly fast speeds.The patient was unable to be treated and was rescheduled.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key13578502
MDR Text Key285944406
Report Number1282497-2022-00021
Device Sequence Number1
Product Code HIH
UDI-Device Identifier10884521744110
UDI-Public10884521744110
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K130215
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/24/2022
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
Device Operator Health Professional
Device Model Number72203012
Device Catalogue Number72203012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/03/2022
Initial Date FDA Received02/22/2022
Supplement Dates Manufacturer Received05/17/2022
06/09/2022
Supplement Dates FDA Received06/01/2022
06/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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