MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE 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 Problems Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is 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.Internal complaint reference: (b)(4).

Event Description

It was reported that on (b)(6) 2019 a routine hysteroscopy, dilation and curretage, and myosure resection of suspicious endometrial polyps was completed.The patient was discharged home, but returned to the emergency room the next day with an acute abdomen.Iv antibiotics and fluids were given and a ct scan of the abdomen and pelvis was done."bloods and imaging confirmed a likely perforated viscus with free air and a 10cc pelvic collection." the patients pathology confirmed a diagnosis of grade 2 endometrial carcinoma with fragments of small bowel muscularis mucosa in the specimen.The patient was taken to the operating room and had a "midline laparotomy, washout, an 8mm small bowel perforation oversewn, tahbso." the patient "is making good progress with her post-operative recovery.".

• Brand Name: MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8469387
• MDR Text Key: 140457162
• Report Number: 1222780-2019-00070
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention