MAUDE Adverse Event Report: COVIDIEN MANSFIELD HYSTEROSCOPIC FLUID MANAGEMENT; INSUFFLATOR, HYSTEROSCOPIC

Model Number	7210164
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during hysteroscopic resection while inside the uterine cavity during myometrial penetration, the surgeon noticed an increased in the fluid deficit level.Surgeon said the deficit was 1000cc at one point.After 5 minutes, deficit was 5000cc.Surgeon said there were no alarms or beeps.Machine was checked later and found to have proper fluid deficit alarming function.It was suggested by surgeon to increased volume of alarm.Nurse did not communicate nor report the deficit during this 5 minutes interval.Patient was given lasix intravenously.Surgeon said patient urine was 4000cc following lasix.There was no change in patient electrolytes and was discharged.All tissue had been resected.Procedure was completed.There was no patient injury.

• Brand Name: HYSTEROSCOPIC FLUID MANAGEMENT
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9660647
• Report Number: 1282497-2020-00006
• Device Sequence Number: 3422245
• Product Code: HIG
• UDI-Device Identifier: 03596010529534
• UDI-Public: 03596010529534
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR