MAUDE Adverse Event Report: MITG - OKLAHOMA CITY HYSTEROLUX FLUID MANAGEMENT SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72205000

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

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 the procedure, the control unit fluid management was not calculating correctly and had deficit as it was shown at maximum however manual calculation showed 500 ml and not 2500 ml.In addition, there were issues fitting the handpieces connector into the control unit as it had a small cracked and when pressed this can be connected but with difficulty.There was no failure of the device in the patients, all issues were outside with the circulation staff.This was an out of box failure since these were brand new and have not previously been used.The procedure was still completed.There was no patient injury.Photos were submitted illustrating the issue with the faulty handpiece connector with cracked.However an alternative handpiece was tried post procedure and this was also difficult to insert.The connections did not aligned in the control unit for the handpiece to connect into.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample met specification as received.The visual inspection found no notable conditions.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.An additional failure was found during the investigation; the scale needed to be calibrated.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.The condition of the product was addressed by calibrating the scale.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.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.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

2020-10-01, 05:02:55, saclas2: reported in error as medtronic is not the legal manufacturer.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.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: HYSTEROLUX FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• MDR Report Key: 8891385
• MDR Text Key: 154253204
• Report Number: 1643264-2019-20015
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04056702005672
• UDI-Public: 04056702005672
• Combination Product (y/n): N
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72205000
• Device Catalogue Number: 72205000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 09/30/2020
• Supplement Dates FDA Received: 12/18/2019; 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1