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

Model Number 72203012

Device Problems Component Falling (1105); Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 10/10/2014

Event Type  malfunction  

Event Description

During a hysteroscopic myomectomy utilizing the truclear ultra reciprocating morcellator, it was reported that inner chamber broke and part of the blade fell into the patient.The report indicates the doctor was attempting to morcellate a large calcified intramural fibroid.When the device broke inside the patient, the doctor removed the device as quickly and safely as possible.She then inserted the scope back into the patient to access the situation and that is when she was able to see two small fragments of the device on the screen.The doctor was able to successfully remove the larger fragment with a grasper, and she was fairly certain she was able to remove the smaller one as well.It was reported that she switched to a resectoscope to complete the remainder of the procedure.The patient was stable and was released from post-op with no complications.

Manufacturer Narrative

Medical assessment: no harm was documented to the patient as a result of the broken device.No xray images are available to confirm no device fragments left insitu.Based on information provided and no additional clinical information provided, no further medical assessment is warranted in this case.(b)(4).

• Brand Name: TRUCLEAR ULTRA RECIPROCATING MORCELLATOR 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4237598
• MDR Text Key: 5065429
• Report Number: 3003604053-2014-00016
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/10/2014

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: 01/31/2017
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: C07420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 11/07/2014
• Date Device Manufactured: 02/01/2014
• 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