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

Model Number 50-601XL

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

Patient Problems Uterine Perforation (2121); Perforation of Vessels (2135)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.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 on (b)(6) 2022, during a myosure procedure, a uterine perforation was observed at the fundus and the patient´s bowel was perforated.A general surgeon was brought in to laparoscopically stitch the patient´s bowel.The patient was in stable condition and would have 6 weeks of recovery time.The patient was being kept in observation.The patient required a diagnostic laparoscopy and the physician performed a laparotomy to fully run the bowel and check for injury.The perforation of the uterus was observed and a rent in the mesentery and serosal defect of the sigmoid colon.No bowel perforation occurred, the uterus was super soft and boggy probable adenomyosis.

• Brand Name: MYOSURE
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15195023
• MDR Text Key: 297555397
• Report Number: 1222780-2022-00212
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 15420045507654
• UDI-Public: (01)15420045507654(17)250320(10)22D05RA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181974
• 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: 08/09/2022

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: 50-601XL
• Device Catalogue Number: 50-601XL
• Device Lot Number: 22D05RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/09/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Female