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

Model Number 30-401LITE

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2021

Event Type  malfunction  

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 Description

It was reported that on (b)(6) 2021, during a myosure lite procedure, metal shavings were observed coming from the device.The device was replaced with a myosure reach and the procedure was completed successfully.The physician performed a hysteroscopy with suction and no debris were left inside the patient.No other information is available.

Manufacturer Narrative

Myosure disposable was received on (b)(6) and was tested by the pms group.Visual inspection was performed and the "tubing" had no kinks or missing components.Mechanical testing was performed and it was found that the blade could reciprocate without obstruction.The dissection testing showed a worn inner canula surface and pieces of metal inside the device.Hence the complaint was confirmed.No additional information available.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 TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 12484432
• MDR Text Key: 272475771
• Report Number: 1222780-2021-00241
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505070
• UDI-Public: (01)15420045505070(10)20L12RJ(17)231112
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/25/2021

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: 11/12/2023
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: 20L12RJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 09/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1