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

Model Number 72203012

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adult Respiratory Distress Syndrome (1696); Edema (1820)

Event Date 07/31/2014

Event Type  Injury  

Event Description

It was reported that during a procedure to remove a fibroid the patient coded in post anesthesia care.Patient edema was aspirating so they switched from monitor anesthesia care to general anesthesia.Sales rep had no information at this time on the fluid deficit or the patients current condition.The doctor did remove a fibroid with the truclear.The blade was part # 72203012; there was an unknown pump used during the procedure; and the surgeon was satisfied with the fibroid removal.No other information regarding patient status is available at this time.

Manufacturer Narrative

No product is being returned for analysis.(b)(4).

• Brand Name: GYN 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 ; 9787491561
• MDR Report Key: 4028324
• MDR Text Key: 4803462
• Report Number: 3003604053-2014-00010
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/21/2014
• 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
• Patient Outcome(s): Other