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

Model Number 50-501XL

Device Problem Use of Device Problem (1670)

Patient Problems Vaginal Mucosa Damage (2124); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Adverse event health effect : proposed code urethral injury.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.

Event Description

It was reported that a 44 years old patient underwent a myosure ablation procedure in (b)(6) 2023 / (b)(6) 2023.The device was successfully tested testing prior to use and it was used in the procedure without any malfunctions.However, at the end of the procedure, the disposable device was not removed prior to the hysteroscope removal as expected: when removing the hysteroscope, the device was still within the hysteroscope and was protruding through the distal end of the hysteroscope.The surgeon¿s foot was either still on the foot pedal and/or she pressed the foot pedal on removing the instrumentation.As a result on removal, the myosure device resected vaginal tissue which lead to anterior vaginal wall and urethral damage.A surgical repair was immediately required and the patient has been catheterized which is to remain in-situ for 3-months.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• 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: 16473276
• MDR Text Key: 310561269
• Report Number: 1222780-2023-00054
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045505094
• UDI-Public: 15420045505094
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142029
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2023
• 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
• Patient Outcome(s): Other