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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
It was reported that on may 6th a patient received a myosure procedure and had to be admitted to the post anesthesia care unit due to a persistent bleeding cause by a fibroid that could not be completely resected.The patient received a uterine artery embolization and was discharged without issues.No other information is available.
Additional Manufacturer Narrative
Myosure disposable was received and tested.Hologic received 3 disposables with the same lot number.The customer didn't specify which device was involved in the procedure hence hologic performed an investigation on all 3 devices.Visual investigation on 3 devices was performed and two of the devices had no kinks or damaged components and one had the suction line cut.Mechanical testing was performed on all 3 devices and all passed and worked as intended.No issues with any of the 3 devices was observed.No issues with the devices was observed.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.Additional information received : it was reported that the bleeding was due to a fibroid that could not be completely resected.No device malfunction was reported.The patient received a uterine artery embolization and was discharged without issues.No other information is 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: 11939930
• Report Number: 1222780-2021-00122
• Device Sequence Number: 4113323
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: (01)15420045505094(10)20H21R(17)230821
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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 Expiration Date: 08/21/2023
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: 20H21R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: Other; Required Intervention