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

Model Number 60-200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) a myosure procedure was performed.Before the procedure, the doctor performed a diagnostic cystoscopy, then used a blade to cut out an adhesion in the cervix, and went in with the 5.5 omni scope to survey the cavity.Immediately the deficit jumped to about 250.The doctor had the nurse to open a myosure lite.At this point, the deficit was hovering around 700.The doctor resected for 4 seconds when the patient started to lose distension in the cavity and the deficit jumped to 1600.The doctor took out the device and inspected the patient for a while, then went back in with just the scope and found the perforation.The procedure was then aborted.The patient was not kept for observation and no additional medication was provided.The doctor did not convert to a laparoscopy procedure as the patient had not consented to laparotomy.No additional information available.

Manufacturer Narrative

Device identifier: (b)(4).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.2 devices were involved in this event: 1222780-2024-00142 and 1222780-2024-00143.

• Brand Name: MYOSURE HYSTEROSCOPE
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102 ; CR 20102
• MDR Report Key: 19061907
• MDR Text Key: 339673839
• Report Number: 1222780-2024-00143
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female