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

Model Number 7209509

Device Problems Material Discolored (1170); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 01/08/2019

Event Type  malfunction  

Event 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
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8309944
• MDR Text Key: 135152858
• Report Number: 8309944
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 03596010529459
• UDI-Public: (01)03596010529459
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 111