MAUDE Adverse Event Report: ANDOVER MANUFACTURING SITE TRUCLEAR; TRUCLEAR ULTRA RECIPROCATING MORC. 4.0

Model Number 72203012

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

It was noted that there was a fluid deficit of 1500ml within a few minutes of dilating the uterus, and inserting the scope and morcellator.Staff member checked to see where the missing fluid had gone while the surgeon proceeded for a short time.The pump was then stopped when the deficit was at 2250ml, thinking the uterus could have a perforation.Sales rep.Indicated she was present during surgery and due to the deficit of fluid she stated that in her opinion, there could have possibly been a perforation.Patient experienced a slight drop in temperature.Due to the high fluid deficit the case was cancelled.The patient was stable and had no symptoms after the procedure and there was no need for medical intervention.The surgeon will have to schedule additional procedure to remove the remaining fibroid as it was not completely removed upon first approach.The surgeon elected not to use the back-up device that was available due to the possibility of a perforation.The surgeon thought the fluid deficit was caused by the associated pump.The pump was subsequently used several times after this incident in other procedures and no fluid deficit was encountered.

Manufacturer Narrative

The device is not being returned for analysis.(b)(4).

• Brand Name: TRUCLEAR
• Type of Device: TRUCLEAR ULTRA RECIPROCATING MORC. 4.0
• Manufacturer (Section D): ANDOVER MANUFACTURING SITE; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): ANDOVER MANUFACTURING SITE; 150 minuteman road; andover MA 01810
• Manufacturer Contact: robert bombard ; 150 minuteman road; andover, MA 01810 ; 9787491561
• MDR Report Key: 3731982
• MDR Text Key: 4312630
• Report Number: 3003604053-2014-00003
• 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: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/07/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/10/2014
• 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