MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE TISSUE TRAP; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

The myosure hysteroscope was inserted and a polyp was morcellated and removed.The tissue was pulled through the tubing and into a collection tissue trap (sock).Because of a series of miscommunication, there was no specimen provided to surgical pathology as the surgeon had requested.At the end of the case debriefing, it was assumed there was no specimen and the specimen was discarded from the device.Approximately one week later, the surgeon inquired about the pathology results for the specimen, it was discovered that the tissue tray (sock) on the myosure collection system was not sent to lab and this specimen was irretrievable and irreplaceable.A root cause of the event finding was that the or staff was unfamiliar with the myosure collection system due to fact that it is rarely used.It was suggested that the manufacturer consider adding a prompt on the tissue trap (sock) to identify that this trap (sock) is not to be discarded as it contains a specimen that should be brought to lab/pathology.

• Brand Name: MYOSURE TISSUE TRAP
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 14985896
• MDR Text Key: 295690121
• Report Number: 14985896
• Device Sequence Number: 1
• Product Code: HIH
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Female