MAUDE Adverse Event Report: HOLOGIC, INC. AQUILEX FLUID CONTROL SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2017

Event Type  malfunction  

Event Description

The surgical scrub tech was setting up the room to perform an evaluation under anesthesia, hysteroscopy and polypectomy with myosure.The aquilex tubing blew at the pump site.There was no damage to the machine and the patient was not yet in the operating room.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 6460244
• MDR Text Key: 71719242
• Report Number: 6460244
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO DEVICES WERE BEING USED, THE PATIENT WAS NOT YE; NO OTHER THERAPIES
• Patient Age: 40 YR
• Patient Weight: 60