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

Model Number 10-401FC

Device Problems Break (1069); Decrease in Pressure (1490); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Team lead (tl) registered nurse (rn) was called into the operating room because the physician had placed the myosure reach extended tissue removal device inside the sheath, the uterine pressure decreased to zero, and she could not visualize anything.The tl rn tried to trouble shoot the machine, and could not find anything wrong.The tl rn called the company representative and he said there have been issues with the myosure handpieces where the opening at the tip get stuck closed.The myosure reach device was removed from the patient, the foot pedal was pressed and the handpiece was stuck, the blade was exposed and the cord was flopping wildly.Per physician post-op note: cervix was dilated.Hysteroscope was introduced with the above finding.Myosure reach device was introduced, however we kept getting losing pressure.No uterine perforation noted.Instruments were changed and still unable to get myosure in.No perforation noted again.At this point, it was decided to just go with the curettage.

• Brand Name: MYOSURE REACH EXTENDED TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 12280198
• MDR Text Key: 265159409
• Report Number: 12280198
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 21D07RD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 58