MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number ULTRA PLUS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Thrombus (2101); Abdominal Distention (2601)

Event Date 02/18/2020

Event Type  malfunction  

Event Description

Patient was taken to the or for elective procedure as indicated below.She was placed in dorsal lithotomy position in allen type stirrups.Patient was prepped and draped in the normal sterile fashion.Next, a weighted speculum was placed in the vagina.The anterior lip of cervix was grasped with a single tooth tenaculum and sounded to 4 cm.The cervix was sequentially dilated to accommodate the 5-mm hysteroscope.A 5-mm 0-degree truclear hysteroscope was introduced under direct visualization, and the uterus was distended with normal saline.Bilateral cornua identified and the aforementioned findings were noted; no perforation was identified with intracavitary survey.The blade was then introduced into the cavity, and under direct visualization the polyp was removed.Sampling of the surrounding lower segment lining was performed; sampling did not occur near the uterine fundus.Endometrial samplings were collected and sent to pathology.After the procedure, all instruments were removed from vagina.The cervix was noted to be hemostatic.At this time, rn noted abdomen to be markedly distended.Per device rep, calculated fluid deficit was 375 ml.Due to abdominal distention, a diagnostic laparoscopy was performed.A 5 mm scope was introduced under direct visualization and insufflation established to a level of 15 mmhg, and two additional 5 mm ports were placed in the bilateral lower quadrants under direct visualization.Intraabdominal survey revealed copious amount of clear fluid, as well as a right-sided fundal perforation that was noted to be hemostatic with a small clot overlying it.The clot was removed, and again hemostasis was observed.Arista was applied to ensure excellent hemostasis.Suction irrigator was utilized to remove as much fluid from the abdomen as possible; approximately 1,000 ml of fluid was removed, revealing a marked discrepancy between actual and machine-calculated fluid deficit.The patient was admitted to the hospital for 23-hour observation.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andove MA 01810
• MDR Report Key: 10017265
• MDR Text Key: 189612090
• Report Number: 10017265
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ULTRA PLUS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Weight: 78