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

Model Number 50-250XL

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

Patient Problem Rupture (2208)

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) a novasure procedure was going to be performed, and before was also used the fluent fluid management system to perform the diagnostic hysteroscopy.The doctor was initially using a non-hologic hysteroscope and while doing so, the attending doctor noted a false passage that was made.The doctor then chose to change to the myosure xl scope.Upon use, the doctor made 2 more false passages in the uterine cavity.No perforation was suspected; no fluid loss during the diagnostic hysteroscopy.The final deficit was 65mls.The attending doctor made it clear there were 3 in total false passages.The doctor chose not to perform the novasure ablation.No further action was taken post-operation.No further patient injury was reported.The patient was sent home without incident and has a follow-up scheduled to discuss the treatment plan moving forward.No additional information available.

Manufacturer Narrative

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.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 XL
• 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: 18978017
• MDR Text Key: 338592293
• Report Number: 1222780-2024-00127
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122563
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-250XL
• Device Catalogue Number: 50-250XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/26/2024
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female