MAUDE Adverse Event Report: HOLOGIC MARLBOROUGH / HOLOGIC SURGICAL PRODUCTS CO MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Model Number 30-401LITE

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

Patient Problem Bowel Perforation (2668)

Event Date 05/07/2022

Event Type  Death  

Event Description

Clinical account manager (cam) is reporting that during the case performed on (b)(6) 2022 the case was posted as a myosure/novasure case.The physician explained before the case that she was no longer going to do an ablation for this patient as the patient decided not to go through with it.The staff used a regular 6.25 myosure scope to do the hysteroscopy.Once inside the cavity, they had great distention and visualization.They ended up pulling a myosure lite to use in the endocervical area to remove a few small polyps.They had great visualization the entire time.The case was very quick, could not have lasted longer than 15 minutes.The final deficit was 132 on the fluent machine.The physician informed cam today that the patient from this case came into the hospital two days later, (b)(6) 2022, and was septic and passed away due to a perforation in the patient.The physician had informed cam that the husband of the patient had called the hospital 3 different times (twice friday and once saturday) to report the patient's symptoms and they advised him to immediately call 911 and bring the patient to the emergency room which he opted not to do until saturday night, which by then, it was too late to save the patient.Physician detailed the case to cam again to let cam know that the myosure blade was not the cause of the perforation nor was the blade resecting bowel or anything else not within the patient's cavity.They had checked the tissue sock to be sure of this.The patient did not sound nor curettage in this case but did use pratt dilators.During this case, they never had the deficit skyrocket, they did not visually see a perforation, and there were no bubbles or fluid rushing towards any particular spots that could have been perforated.There was nothing that occurred that indicated to her that the physician had perforated during the case.

Manufacturer Narrative

On (b)(6) 2022 hologic was made aware of this event.The hologic rep was present for the procedure on (b)(6) 2022, however the case was completed on that date without any complications.It was reported that during the case on (b)(6) 2022, the physician explained they would no longer be performing the planned novasure ablation because the patient decided not to go through with that procedure.The staff used a standard 6.25mm myosure hysteroscope to perform the hysteroscopy.It was noted that distension and visualization was great in the cavity.The physician used a myosure lite to remove some small polyps in the endocervical area of the patient.The procedure was completed successfully in a short period of time, estimated to have taken less than 15 minutes in total.The fluid deficit recorded on the machine was 132ml.The procedure was unremarkable with no observed complications or indication of an injury to the patient.On (b)(6) 2022, the physician contacted the hologic rep and informed them that the patient had returned to the hospital two days later on (b)(6) 2022.The patient presented and was septic.The patient passed away and it was determined to have been caused by a perforation.It was reported to hologic that the patient's husband had called the hospital 3 times to report the patient's symptoms, however they opted to not call 911 and go to the emergency room.It was reported to hologic that by this time it was too late to save the patient.The physician reported to the hologic rep that the myosure blade was not the cause of the perforation nor was the blade resecting bowel tissue, or any other tissue not within the patient's cavity.The tissue sock was checked to verify there was no tissue from outside of the endocervical area.The physician confirmed the fluid deficit value did not "skyrocket", if there was a perforation created during the procedure then it would be expected to see a rise or jump in the fluid deficit.Additionally, the physician did not observe any bubbles, or fluid movement towards any areas that could have been perforated.There were no indications that the physician perforated during the case.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: MYSOURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC MARLBOROUGH / HOLOGIC SURGICAL PRODUCTS CO; 562 parkway; coyol free zone building b24; san jose 20102 ; CS 20102
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, MA 01752 ; 5082638713
• MDR Report Key: 14893233
• MDR Text Key: 295219532
• Report Number: 1222780-2022-00176
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/01/2022

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: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/01/2022
• 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): Death
• Patient Sex: Female