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

Model Number	7209509
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
5 different truclear incisor plus devices opened from sterile peel pack.The tips of incisors had brown discoloration and debris (lint).This was caught prior to patient contact and the procedure was completed as planned.The remaining packs in inventory were inspected and replaced as necessary.Manufacturer response for hysteroscope (and accessories), truclear tm incisor tm plus device (per site reporter).The field rep was present at the time of the event and took the affected products.

• Brand Name: TRUCLEARTM INCISORTM PLUS DEVICE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8309944
• Report Number: 8309944
• Device Sequence Number: 16716423
• Product Code: HIH
• UDI-Device Identifier: 03596010529459
• UDI-Public: (01)03596010529459
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2019
• Report Date (Section F): 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 7209509
• Device Catalogue Number: 7209509
• Device Lot Number: 3895171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 111
• Date Report Sent to FDA: 01/21/2019