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 Problem Bacterial Infection (1735)

Event Date 03/29/2023

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.

Event Description

It was reported that a patient received an acessa procedure on (b)(6) 2023 without any complications.It was a myomectomy with myosure followed by a laparoscopic rfa with acessa of one fibroid and a laparoscopic salpingectomy.All procedures anticipated.A month later the patient reported pain wars worsening and that her bleeding had improved.At 5.5 post op the patient was admitted to the emergency room due to pain and fever.Blood work revealed white cell count at 20 000.A ct scan was performed without any significant changes, no fluid collection, no abscess and changes around the uterus.The patient was admitted to the hospital, put on iv antibiotics and currently is hemodynamically stable.The patient was kept in the hospital and showed signs of improvement from the infection.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 20102 ; CR 20102
• MDR Report Key: 16970203
• MDR Text Key: 315684850
• Report Number: 1222780-2023-00183
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045510333
• UDI-Public: 15420045510333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-250XL
• Device Catalogue Number: 50-250XL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2023
• 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; Hospitalization