MAUDE Adverse Event Report: HOLOGIC INC MYOSURE LITE; HYSTEROSCOPE WITH POLYP REMOVER

Model Number 30-40LITE

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

Patient Problems Cardiac Arrest (1762); Death (1802); Pulmonary Edema (2020)

Event Date 12/28/2017

Event Type  Death  

Event Description

Cardiac arrest and pulmonary edema during elective hysteroscopy.Pt subsequently died.

• Brand Name: MYOSURE LITE
• Type of Device: HYSTEROSCOPE WITH POLYP REMOVER
• Manufacturer (Section D): HOLOGIC INC; marlborough MA
• MDR Report Key: 7218081
• MDR Text Key: 98292034
• Report Number: 7218081
• Device Sequence Number: 1
• Product Code: HIH
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2020
• Device Model Number: 30-40LITE
• Device Lot Number: 17G10RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/17/2018
• Distributor Facility Aware Date: 12/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 60