MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUCLEAR ULTRA RECIPROCATING MORC. 4.0; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 72203012

Device Problems Device Inoperable (1663); Unintended Movement (3026)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

It was reported that the device entered the uterus and started to morcellate the fibroid when the surgeon noticed it was not working.In view of the patient metallic ends were floating inside the uterus.The device was then removed and it was noticed the device was not reciprocating and therefore not working.The metal pieces were removed from the patient through suction with the back-up morcellator.

Manufacturer Narrative

Inspection of the returned device indicated the following: there was evidence that the outer blade had been bent at the distal end.In addition, the inner blade had a deformation on the distal cutting edge.The outer blade showed scratch marks.The device was disassembled to inspect the internal components, and it was noted that the inner blade was sheared off towards its proximal end.Additionally it was noted that the distal end of the inner blade had heavy scratches that resulted in removing a section of the laser mark on this blade.Because the scratch marks are circumferential and do not follow a helical pattern, this indicates that a foreign hard object introduced these scratches on both the inner and outer blades.The presence of these scratch marks on the outside of the outer blade as well further reinforce the possibility of a foreign hard object presented, since this surface does not see any scratches during standard usage.Any hard object introduced between the inner and outer blade can cause the inner to get off trajectory and collide with the outer blade.At this point, it is unclear what this object may have been as it was not found within the blade assembly.Based upon these observations, no further action is warranted at this time.(b)(4).

• Brand Name: TRUCLEAR ULTRA RECIPROCATING MORC. 4.0
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4840924
• MDR Text Key: 5933136
• Report Number: 3003604053-2015-00027
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• 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 Expiration Date: 08/01/2016
• Device Catalogue Number: 72203012
• Device Lot Number: B76962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• 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: 09/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR