MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number TRUCLEAR 5.0

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2019

Event Type  malfunction  

Event Description

Smith and nephew hysteroscopy fluid management system incorrectly calculating fluid deficit when using large volumes of fluid.This is the 2nd case in less than a month that had to be aborted due to fluid system calculating fluid overload.After first time this happened, vendor was notified and fluid management system was sent to repair.Machine has been returned but is still not working correctly.Manual count of fluid showed deficit of 1120 while fluid system was reporting close to 2500 which is the fluid deficit cut off.Hysteroscopy portion of case aborted and manual removal of polyp performed.Smith and nephew vendor was notified.Manufacturer response for smith and nephew hysteroscopy fluid management system, (brand not provided) (per site reporter).Medtronic sales representative came on site to check the unit and reported issue was verified.According to sale rep, the scale was not accurate which caused fluid deficit.A replacement unit will be sent at no charge.A loaner unit cn: l40036 was provided to be used before replacement unit is received.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms parkway; cordova TN 38016
• MDR Report Key: 10726294
• MDR Text Key: 212725816
• Report Number: 10726294
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TRUCLEAR 5.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 62