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

Model Number 50-601XL

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 07/05/2023

Event Type  Injury  

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.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.A video provided by the customer showed the deformation of the device.Hence the complaint can be confirmed.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 july 6th, a myosure procedure was performed, and during the procedure, there was a lot of resistance deploying the cutting blade down the hysteroscopes that was being used.When the physician had finished resecting, he attempted to pull the cutting blade to remove it from the scope and accidentally cut the patient's cervix.The patient received stitches to stop the bleeding and was reported to be fine after the procedure.No additional medical intervention required.A video was provided by the customer in which resistance could be observed in the interaction between the myosure blade and the hysteroscope but no additional details were provided.

• 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 20102 ; CR 20102
• MDR Report Key: 17413928
• MDR Text Key: 319963499
• Report Number: 1222780-2023-00256
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045507654
• UDI-Public: (01)15420045507654(17)251025(10)22L10RA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 22L10RA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OMNI HYSTEROSCOPY STANDARD SET
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female