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

Model Number 10-401FC

Device Problem Insufficient Information (3190)

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

Event Date 04/02/2021

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 april 2nd while performing a myosure procedure, the physician observed that the blade was not present in the cutting window.The physician performed a x-ray to check for debris in the uterine cavity the results were negative.The procedure was completed using a second device.No other information is available.

Manufacturer Narrative

Myosure disposable arrived at hologic costa rica on (b)(6) and was tested by the pms group.Visual inspection was performed, and everything worked as intended, no missing or damaged components.The mechanical testing was performed, and the blade could reciprocate the movement, but never returned to closed position.The device was dissected, and the inner cannula was corroded, which created resistance to the cannula movement which caused the blade not returning to closed position which suggested that the blade might had dissembled from the device and give the impression of being in the uterine cavity.No pieces from the device were missing.Hence the complaint about parts of the device inside the uterine cannot be confirmed.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.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 11658752
• MDR Text Key: 245804674
• Report Number: 1222780-2021-00076
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: (01)15420045504530(10)20L19RD(17)231119
• Combination Product (y/n): N
• PMA/PMN Number: K152723
• 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: 09/09/2021

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: 11/19/2023
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: 20L19RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other