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

Model Number 50-250XL

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

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

Event Type  Injury  

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.Both devices involved in this event are reported under : 1222780-2022-00137.

Event Description

It was reported that on an unknown date, a patient received a myosure and myosure hysteroscope procedure.The patient went home where she became extremely unwell and presented to the hospital.The patient was taken for a laparotomy, and it was found that a bowel injury had occurred, and her peritoneal cavity was found to be full of fecal matter and free fluid.The peritoneal cavity was cleaned, and the patient was scheduled for a surgery to repair the bowel and a hysterectomy.The patient was extremely unwell, and she spent a few days in the icu.No other information is available.

Manufacturer Narrative

Additional information received : the patient is doing well.Report received by physician : patient had history of postmenopausal bleeding and history of two cesarean sections.The operation performed was a hysteroscopy and a resection of suspected submucous fibroid with a myosure lite.A large submucosal lesion was observed , probable myoma, the lesion felt gritty and calcified.Mirena was not inserted due to defective area along the fibroid.Patient was sent home on oral antibiotics.No lasting effects of the procedure.Hysterectomy performed due to endometrial cancer diagnosed on endometrial tissue sample.No additional treatment was administered.No other information is available.

• Brand Name: MYOSURE XL HYSTEROSCOPY SET
• 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, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 14402202
• MDR Text Key: 291738082
• Report Number: 1222780-2022-00130
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122563
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-250XL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE XL TRD.
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Sex: Female