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

Model Number	10-550
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a myosure procedure on (b)(6) 2020, 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.No other details provided.
Additional 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 CONTROL UNIT
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11093088
• Report Number: 1222780-2020-00181
• Device Sequence Number: 19912083
• Product Code: HIH
• UDI-Device Identifier: 15420045505117
• UDI-Public: (01)15420045505117(11)150901
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10-550
• Device Catalogue Number: 10-550
• Device Lot Number: H3469I15D0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1