MAUDE Adverse Event Report: MITG - OKLAHOMA CITY HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND; INSUFFLATOR, HYSTEROSCOPIC

Model Number 7210165S

Device Problem Incorrect Measurement (1383)

Patient Problem No Information (3190)

Event Date 07/23/2019

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 testing, the device was not reading fluid deficits properly off by 300+.

Event Description

According to the reporter, during testing, the device was not reading fluid deficits properly off by 300+.There was no patient involved.

Manufacturer Narrative

Additional information: evaluation summary: one device was received for evaluation.The returned sample met specification as received.The visual inspection found there was no indications of transport damage, the scale is in poor overall condition, the bag deflector had many deep scratches and 5 wall plates were faded or stained.The customer reported that the device was not reading fluid deficits properly off by 300+.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found that the unit passed the self test, a scale test and deficit testing were performed and were found to be within specifications.The investigation found the device to function normally and within specifications.All replacement parts were installed, the unit was calibrated, was fully tested and is functioning per specifications.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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM STAND
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• MDR Report Key: 8910858
• MDR Text Key: 154907775
• Report Number: 1643264-2019-20016
• Device Sequence Number: 1
• Product Code: HIG
• 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
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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: 7210165S
• Device Catalogue Number: 7210165S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1