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

Model Number 50-501XL

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

Patient Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Type  Injury  

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.

Event Description

Hologic was contacted by a uk consultant to report a patient adverse event.He indicated that he is not connected to the incident but is working on the case.The incident happened in another hospital, but he was not allowed to specify which hospital and physician(s) involved.It was reported that a 58 years old patient underwent a myosure ablation procedure in (b)(6) 2022 (no precise date).The patient is nulliparous.She had postmenopausal bleeding, a 6cm intrauterine fibroid, and was booked for an outpatient myosure procedure.Unfortunately, during the procedure, the patient ended up with a uterine perforation, and the bowel resected.She has now a stoma.All attempts to obtain additional information were unsuccessful.The reporter indicated that he was not allowed to share more details on this event.

Manufacturer Narrative

G2 please refer add report source foreign.(uk).

• 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
• MDR Report Key: 18024865
• MDR Text Key: 326791759
• Report Number: 1222780-2023-00402
• Device Sequence Number: 1
• Product Code: HIH
• 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,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 10/11/2023
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization