MAUDE Adverse Event Report: COVIDIEN MANSFIELD TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 7209807

Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 a procedure, at the start of the procedure, when running a dense tissue shaver plus device on the handpiece with a scope and a tissue shaver, it jammed and failed to rotate.Switched handpieces and blades and again experienced the same issue.The procedure was cancelled, then rescheduled and completed using another equipment.Patient was under anaesthesia.There was no patient injury.

Manufacturer Narrative

Additional information: g3, h6 information received shows that this event is a duplicate of another issue reported under regulatory report # 1282497-2022-00005.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: g3, h3, h6 correction: d9 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the shaft depth was not within tolerance.The tolerance is 1.960 to 1.980 inches.This measured at 1.953 inches.The depth needs adjusted and rtv applied.The speed of the handpiece was tested at 2500 rpm with a tachometer.This was the max that the control unit will go.The tachometer read 2490 rpm.There was no fault found with the motor.It was reported that there was an adverse event without an identified device or use problem and the device would not oscillate.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a value that was out of specification.The most likely cause for the additional condition is traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.

• 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 Key: 13489177
• MDR Text Key: 285347564
• Report Number: 1282497-2022-00005
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 03596010501943
• UDI-Public: 03596010501943
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

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 Number: 7209807
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 06/14/2022
• Supplement Dates FDA Received: 05/07/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other