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

Catalog Number 7209808

Device Problem Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

It was reported the device is shorting out with hand piece.

• Brand Name: TRUCLEAR CONTROL UNIT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX
• MDR Report Key: 7005590
• MDR Text Key: 91539309
• Report Number: 1643264-2017-01514
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/07/2017

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 Catalogue Number: 7209808
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 11/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1