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

Model Number 10-550

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the device not provided by the complainant, therefore the udi, expiration and manufacturing dates are not known.

Event Description

It was reported that during a myosure procedure on december 2nd, myosure control unit was powered on and almost instantly the window display goes out and the device won't cut.In many cases were not even attempted to be used and no foot pedal was activated.The case was about two hours in length and patient went from local anesthesia to general.

Manufacturer Narrative

Results from the investigation of the product : controller passed functional testing.Complaint not verified.This observation will be monitored and trended.Standard dhr review|a device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.

• Brand Name: MYOSURE TISSUE REMOVAL SYSTEM CONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11069809
• MDR Text Key: 223603580
• Report Number: 1222780-2020-00180
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2021
• Date Manufacturer Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention