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

Model Number 72203012

Device Problems Image Display Error/Artifact (1304); Mechanics Altered (2984)

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

Event Date 10/08/2013

Event Type  malfunction  

Event Description

During an unknown surgery using the truclear ultra reciprocating morcellator, it was reported that the blade allowed too much fluid to come through while window locked and the visualization was poor.The procedure was reported to be extended 5 minutes to regain visualization.There was no impact to the patient during surgery.There were no reported patient injuries or complications.

Manufacturer Narrative

This medical device report (mdr) is being submitted by smith & nephew, inc., (b)(4), as part of a remedial action following the issuance of the 483 issued march 26, 2015 to smith & nephew, inc., fei no: (b)(4).This mdr is being filed in an abundance of caution.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a.As described in our response to the 483, smith & nephew, inc., (b)(4) is engaging an independent clinician to evaluate whether loss of distension could be considered a serious injury per 21 c.F.R § 803.3.Based on the analysis provided by this independent clinician, smith & nephew, inc., (b)(4) will determine whether such events do meet the reporting requirements of 21 c.F.R.Part 803.In addition, in response to the 483, smith & nephew, inc., (b)(4) is in the process of improving its mdr assessment process and reporting procedures to help ensure reports are appropriately filed with the agency.Included within these improvements is a retrospective review of complaints not previously reported to the agency to verify reporting decisions in accordance with the improved process.Accordingly, smith & nephew, inc., (b)(4) may be retrospectively filing additional events, if required, to the agency.(b)(4).

Manufacturer Narrative

(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: 4685831
• MDR Text Key: 5717097
• Report Number: 3003604053-2015-00007
• 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,Followup
• Report Date: 10/08/2013

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: 12/01/2015
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: A87820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/08/2013
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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