MAUDE Adverse Event Report: ANDOVER MANUFACTURING SITE TRUCLEAR

Model Number UNKNOWN

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

Patient Problem Distress (2329)

Event Date 08/05/2014

Event Type  Injury  

Event Description

The patient's cervix was hard to dilate and requested lacrimal dilators.Surgeon had trouble getting the scope into the patient so the s&n sales rep, who was present during the case, recommended that surgeon use the obturator to make inserting the sheath easier.Once the sheath and scope were in the patient, it felt that the scope was in a false passage and not in the uterus based on the picture that we were seeing.Surgeon pointed to what she identified as fibroids and asked for the blade to remove them.The fluid deficit was climbing and was at 1200ccs and again at a deficit of 1300ccs.After removing the tissue surgeon removed the blade but kept the scope in the patient and then commented on how much scar tissue was present.The scope was removed and reinserted into the patient; however, the surgeon had some difficulty inserting back in.Fluid deficit was at 1700ccs.The anesthesiologist then asked the surgeon to take the scope out of the patient because the patient's "levels" were dropping.The anesthesiologist injected something into the patient and after a few seconds told the surgeon that she could continue.Surgeon again used the obturator to insert the sheath and when the tip of the scope was in the cervix, she turned the inflow on and the fluid management system ran out of saline.While new saline was being added, the patient's co2 level dropped and the anesthesiologist the surgeon to stop the case.The fluid deficit had reach 2100ccs of saline and the staff called a "code" for the patient.No other information regarding the case and post-op status of the patient is available at this time.

Manufacturer Narrative

Device is not being returned for analysis.(b)(4).

• Brand Name: TRUCLEAR
• Type of Device: TRUCLEAR
• 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: 4044331
• MDR Text Key: 15104238
• Report Number: 3003604053-2014-00011
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/08/2014

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/28/2014
• 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): Required Intervention