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

Model Number 7210164

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

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 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
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN MANSFIELD; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9660647
• MDR Text Key: 177587627
• Report Number: 1282497-2020-00006
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 03596010529534
• UDI-Public: 03596010529534
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 7210164
• Device Catalogue Number: 7210164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 02/03/2020
• 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 Age: 28 YR