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

Model Number 10-401FC

Device Problem Use of Device Problem (1670)

Patient Problem Uterine Perforation (2121)

Event Date 07/24/2023

Event Type  Injury  

Event Description

It was reported that during a myosure and omni hysteroscope procedure on (b)(6) 2023 the physician reported that the patient was stenotic, and he was able to dilated enough to insert the myosure and omni hysteroscope together but at this point the deficit began to rise rapidly and the physician at this point stopped the procedure and confirmed visually a perforation.The total deficit was 350 ml.The physician was able to complete the procedure using a curette and the patient was given antibiotics.No other information is available.

Manufacturer Narrative

D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: 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.

• Brand Name: MYOSURE REACH
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 17498487
• MDR Text Key: 320779185
• Report Number: 1222780-2023-00264
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045504530
• UDI-Public: 15420045504530
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 60-200
• Patient Outcome(s): Other