MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUCLEAR INCISOR TISSUE REMOVAL DEVICE; GYNECOLOGICAL

Model Number 72202536

Device Problem Material Perforation (2205)

Patient Problem Tissue Damage (2104)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since the lot number was not provided, this information cannot be determined.

Event Description

Pre and post-op diagnosis: fundal fibroid, post-menopausal.The device was applied to the uterus.According to the reporter, during a hysteroscopy procedure, the doctor perforated the fundus with the device.The fluid management system alarmed and deficit rose.The doctor elected to abort the procedure due to perforation.Final fluid deficit was 1050ml of nacl with a total volume of 2200ml of nacl.The patient will remain in the surgery center until 1900 this evening where they will monitor her closely.Medical intervention was required.There was uterine perforation as a result of the problem.The damage will heal naturally.The perforation was due to surgeon error.The device was confirmed to be not defective by the reporter.

• Brand Name: TRUCLEAR INCISOR TISSUE REMOVAL DEVICE
• Type of Device: GYNECOLOGICAL
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 75 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6104308
• MDR Text Key: 59966001
• Report Number: 1643264-2016-20001
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2016

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?: No
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/15/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention