MAUDE Adverse Event Report: MITG - OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72202536

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

Patient Problems Abdominal Pain (1685); Injury (2348)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, post-operatively, he dilated then tried to go in with the scope, but said the cervix tightened up so he dilated up again.Once he went back to the scope and turned on the inflow, the deficit rose quickly.He looked for any fluid on the floor or coming down the back of the drape but saw none.The cavity did not look normal according to him.The representative told him that the fluid deficit was increasing and he wanted to use the incisor device to get a very quick sample under direct visualization.His window locked outside the cavity then ran the blade at 800 and they were at 60 pressure to get a sample of the tissue he saw.Once the deficit got up to 1080 he stopped and finished with a blind d<(>&<)>c.He ran the device in saline briefly at the end of the case to get any remaining tissue in the tubing into the tissue sock.The end total fluid deficit was 1080.Patient was stable a nd was transferred to the recovery room.The patient had a complication from this procedure.The patient was very pale and was complaining of stomach pain in recovery a few hours later so they did a ultrasound and proceeded to take the patient back into the operating room to see the cause of the pain.The patient had undergone for ultrasound as a result they ended up doing a bowel repair and a hysterectomy on this patient.Patient is doing well.The patient was alive with injury.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer (Section G): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7238173
• MDR Text Key: 98908338
• Report Number: 1643264-2018-02015
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202536
• Device Catalogue Number: 72202536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 02/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention