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

Model Number 20-401ML

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

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

Event Type  malfunction  

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/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.

Event Description

It was reported that during a myosure procedure, while removing the device from the uterus the outer metal sheath came off while still inside the uterus.The physician removed the sheath gently without issues.There was no injuries to the patient reported.No other information is available.

Manufacturer Narrative

The device was received and tested.It passed visual inspection with no observable defects and performed as intended during mechanical testing since the device operated well, without any noise or obstruction.However, it was confirmed that if the outer tube was pulled, it came off of the assembly.Therefore, it was confirmed that the outer tube was not adhered correctly to the outer tube hub.The reported observation was confirmed and it will be monitored and trended.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.

• Brand Name: MYOSURE MANUAL TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11596801
• MDR Text Key: 243656243
• Report Number: 1222780-2021-00065
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 154120045507937
• UDI-Public: (01)154120045507937(17)230921(10)20J21RC
• Combination Product (y/n): N
• PMA/PMN Number: K173091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 20-401ML
• Device Catalogue Number: 20-401ML
• Device Lot Number: 20J21RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other