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

Model Number 50-501XL

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Event 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
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 9218176
• MDR Text Key: 163186604
• Report Number: 9218176
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(10)18M19RV(17)211219
• 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: 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
• Device Operator: No Information
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 18M19RV
• 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: 10/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Weight: 97