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

Device Problem Incorrect Measurement (1383)

Patient Problem No Information (3190)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

Aquilex machine # (b)(4) was recording the deficient incorrectly.The machine kept going up.Surgeon was trying to finish procedure.The surgeon decided that he had finished.The machine was tagged and taken out of service.

• Brand Name: AQUILEX
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 7024365
• MDR Text Key: 91784860
• Report Number: 7024365
• 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: 10/20/2017

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: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 36 YR