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

Model Number 72202536

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Upon use of product during a laparoscopic procedure, it was noted that multiple silver metal flecks were deposited from the device into the patient.Pictures were taken.The device was removed immediately after discovery.The metal flecks were removed.Another device was opened and the case was not delayed.

• Brand Name: TRUCLEARTM INCISOR DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms parkway; cordova TN 38016
• MDR Report Key: 8179048
• MDR Text Key: 130984865
• Report Number: 8179048
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202536
• Device Catalogue Number: 72202536
• Device Lot Number: 4312835
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18980 DA