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

Model Number 30-401LITE

Device Problem Material Erosion (1214)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.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 Description

It was reported that during a myosure procedure on (b)(6) 2021 , small metal fragments were observed coming from the myosure device.The physician removed all the metal from the uterine cavity and did a flushing with saline solution.The physician decided to perform a x-ray image for safety and there were no metal fragments observed.The patient didn´t had a history of iud.The patient was doing well.No other information is available.

Manufacturer Narrative

Myosure disposable received on (b)(6) and was tested by the pms group.Visual inspection was performed and had no kinks or missing components.The mechanical testing was executed and could reciprocate without obstruction but the blade did never return to closed position.The dissection testing shows the blade was bent however it looks not damaged.The outer tube had some corrosion.Hence the complaint can't be confirmed, however a bent blade issue can be confirmed.This observation will be monitored and trended.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 12271406
• MDR Text Key: 265004016
• Report Number: 1222780-2021-00213
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505070
• UDI-Public: (01)15420045505070(10)20C26RB(17)230326
• Combination Product (y/n): N
• PMA/PMN Number: K142029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 20C26RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1