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

Model Number 72203012

Device Problems Break (1069); Device Damaged Prior to Use (2284); Mechanics Altered (2984)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a hysteroscopy with myomectomy, the device was not functioning.After diagnosing the problem, it was brought to their attention that the slush chamber on the back of the device was missing.A new device was pulled for use to complete the case.There was no patient injury.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the sluff chamber was missing and was not returned.The customer reported that the device broke prior to application with no consequences or impact to the patient.The reported condition was confirmed.The investigation found the sluff chamber was missing.The chamber may have been removed before use.Post market vigilance investigation (pmv) could not determine when the chamber went missing.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman rd.; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman rd.; andover MA 01810
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7518470
• MDR Text Key: 108489169
• Report Number: 1643264-2018-02047
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 10884521744110
• UDI-Public: 10884521744110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: G09524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 07/26/2018
• Supplement Dates FDA Received: 05/29/2018; 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1