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

Model Number 7210165

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during hysteroscopy myomectomy, the legacy fluid management scale went into an extended ¿bag mode¿ for ap proximately 7-8 minutes which reset to an incorrect deficit reading.A manual count was performed and the fluid deficit limit was reached.The case was stopped due to reaching the maximum fluid deficit, which was calculated by performing a manual count.There was no patient injury.No additional details are available.

Manufacturer Narrative

Additional information: d3 (mfr name, street 1, mfr city, mfr region, serial number), d10, g4, h3, h6 h3 evaluation summary: one device was received for evaluation.The returned sample did not meet specification as received.The visual inspection found there were no indications of transport damage.The bag deflector had some scratches, the rear panel on the display housing is bent, the wall plates are discolored and the display housing is damaged with some sharp edges.The reported condition was duplicated.The investigation found the initial self test failed, error e02 triggered due to the scale being out of calibration which affects the communication between the pump and the scale.The scale has never been serviced since it was produced in june of 2014.The investigation identified the root cause of the reported event to be a maintenance issue.All replacement parts were installed, the device was calibrated, fully tested and is functioning per specifications.A review of the risk file confirmed the failure mode, occurrence, hazard and the overall risk category was addressed adequately as no discrepancies were identified.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 OK 02048
• MDR Report Key: 9215904
• MDR Text Key: 165795648
• Report Number: 1643264-2019-20022
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 03596010529541
• UDI-Public: 03596010529541
• Combination Product (y/n): N
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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 Number: 7210165
• Device Catalogue Number: 7210165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1