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

Model Number AQ100

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

Patient Problem Laceration(s) (1946)

Event Date 01/07/2019

Event Type  malfunction  

Event Description

A surgical technologist reported that case was using a myosure device.When she was taking canisters out to suction fluid, a white plastic disc attached to the device pole sliced open her glove and index finger.The manufacturer was contacted and stated that the white disc could not be removed due to the scale being wired through that portion of the device.This did not come in contact with the patient, and the staff member was inspected by occupational health, with no lasting damage reported.Manufacturer response for pump, circulating fluid, aquilex (per site reporter).The manufacturer stated that the portion of the device could not be moved or removed due to wiring for the scale function of the device.It was returned to the manufacturer since it was due for a pm.A replacement device was sent for the department to use.

• Brand Name: AQUILEX
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 35 crosby dr.; bedford MA 01730
• MDR Report Key: 8314526
• MDR Text Key: 135354933
• Report Number: 8314526
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2019

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: Health Professional
• Device Model Number: AQ100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1