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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. TRUCLEAR ULTRA RECIPROCATING MORC. 4.0; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
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).
 
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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 Key4685831
MDR Text Key5717097
Report Number3003604053-2015-00007
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041774
Number of Events Reported1
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 Date12/01/2015
Device Model Number72203012
Device Catalogue Number72203012
Device Lot NumberA87820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/08/2013
Initial Date FDA Received04/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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