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

Model Number	50-501XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.A device history record (dhr) review was conducted for the reported lot.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.
Event or Problem Description
It is reported that on (b)(6) 2020 a physician performed a myosure procedure on a patient , with the aquilex fluid pump, during the procedure the fluid deficit went up to 2135 so the surgeon wanted to check for perforation in uterus.Hysteroscopy was done and unable to detect if a perforation had occurred so it was decided to perform a diagnostic laparoscopy.The laparoscopy revealed no perforation in uterus nor blood in abdomen.No other findings available.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 10829629
• Report Number: 1222780-2020-00152
• Device Sequence Number: 11044708
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(10)20C10RZ(17)230310
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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 Expiration Date: 03/10/2023
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 20CR10Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention