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

Device Problems Mechanical Problem (1384); Improper Flow or Infusion (2954)

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

Event Date 09/04/2015

Event Type  malfunction  

Event Description

Resectoscope was inserted with a wire loop.Fibroid was completely resected with the wire loop using 100 watts coagulation and cutting current.The fibroid bed and part of the uterus was successfully ablated; however, the fluid machine which they were using registered over 1000 ml, although by their count they only had 700 ml deficit.The machine shut off, it would not allow any more fluid.The procedure was then terminated having partially ablated via endometrial lining.The resectoscope was removed.The patient was taken to the recovery room in stable condition.Manager of surgery will meet with manufacturer's representative to discuss issues we were having with this machine during the case.This was a new machine and the fluid flow was noted to be fast.

• Brand Name: AQUILEX
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 5147793
• MDR Text Key: 28255775
• Report Number: 5147793
• 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
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR