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

Catalog Number 7209808

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/25/2013

Event Type  malfunction  

Event Description

When attempting to plug in the shaver the port that the shaver plugs into pushed right into the machine.Therefore device operator was unable to use the unit.A competitor's device (resector scope) was used to proceed and that is why it took much longer to get through the case.This unit was just received (b)(4).

Manufacturer Narrative

Result: \ investigation confirmed that connecting plug was pushed into the controller.Reported complaint was confirmed.Handpiece receptacle is broken and has been pushed into the inside of the chassis.User may have used too much force when inserting the hand piece.No further investigation is warranted at this time.

• 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 651
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 651
• Manufacturer Contact: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4840334
• MDR Text Key: 5937082
• Report Number: 1643264-2015-00023
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• 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