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

Catalog Number 72203012

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/31/2014

Event Type  malfunction  

Event Description

During a cervical fibroid removal procedure, the sales representative reported that a piece of the blade broke off in the patient.The broken piece was a small sliver from the inner lumen and came out with the fluid.There was no patient injury and the procedure was able to be successfully completed with the backup blade.

Manufacturer Narrative

The allegation of a broken blade was confirmed and was attributed to interference that occurred between the inner tube cutter and the window of the outer tube while the device was used to resect fibroid tissue in the cervix.This typically occurs when the tissue is approached at an atypical, albeit necessary, angle to access it.No manufacturing related defects were observed.(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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4840923
• MDR Text Key: 5939199
• Report Number: 3003604053-2015-00024
• 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: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• 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: 10/31/2017
• Device Catalogue Number: 72203012
• Device Lot Number: C72978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• 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: 11/01/2014
• 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