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

Model Number	50-501XL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Myosure xl hand piece leaking at base of hand piece and tubing connection.Replaced w/ another myosure xl which worked well as described in the procedural notes."the myosure reach was inserted through the operative hysteroscope into the endometrial cavity and the two visualized polyps were resected.After the posterior fundal polyp was removed, the bilateral tubal ostia were visualized and no abnormalities were noted.The myosure reach was then removed and replaced with the myosure xl which was used to remove that portion of the submucosal fibroid that was protruding into the endometrial cavity." no adverse patient outcomes.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 9218176
• Report Number: 9218176
• Device Sequence Number: 19516517
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(10)18M19RV(17)211219
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019
• Report Date (Section F): 10/08/2019

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
• Operator of Device: No Information
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 18M19RV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 10/08/2019