MAUDE Adverse Event Report: SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUECLEAR HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 722000024

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 06/14/2016

Event Type  malfunction  

Event Description

During a hysteroscopy with resection of endometrial polyp and dilation and curettage procedure for what was a large endometrial polyp arising posteriorly, a crack occurred in one of the fluid collector canisters.A sales person for the canister was in attendance.In the process of rectifying the situation, a significant amount-over 2000mls- of saline irrigation fluid leaked onto the operating room floor and around the machine itself.Because of difficulty in adequately recording saline deficits, the case was terminated after the polyp shaved down approximately 75%.There were no other complications.Equipment was on loan and sales rep was present in operating room to observe the malfunction.

• Brand Name: TRUECLEAR HYSTEROSCOPIC FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW INC., ENDOSCOPY DIVISION; 150 minuteman road; andover, MA 01810
• MDR Report Key: 5802663
• MDR Text Key: 49903689
• Report Number: 5802663
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 722000024
• Other Device ID Number: 72202720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR