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

Model Number UNKNOWN TRUCLEAR DEVICE

Device Problem Incorrect Measurement (1383)

Patient Problem No Information (3190)

Event Date 02/28/2020

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 a myomectomy while resecting the tissue, the unit was reading a negative deficit when the case was at negative 800.At the end of the procedure, the manual count was a lot higher than 2500.It was noted that there was fluid on the floor which would contribute to the loss.The electrolyte was asked to be taken to complete the case.

• Brand Name: UNKNOWN TRUCLEAR DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 9882444
• MDR Text Key: 185012025
• Report Number: 1282497-2020-00010
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN TRUCLEAR DEVICE
• Device Catalogue Number: UNKNOWN TRUCLEAR DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1