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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284580
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2017
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The device was received at the service center and evaluated.The following repair activities were performed: performed service and repair functions.Reviewed service history.Attached box label, and electrical safety.The unit was evaluated and the reason for return (poor suction) could not be duplicated.The unit passed all diagnostic tests, functional tests, and is fully operational.Replaced worn fingers on complete pressure adjuster (preventive maintenance) with tip replacement kit.The root cause of the reported failure was undetermined.A batch record review has not been conducted for device because it was manufactured by fms in nice, france.This facility was closed by the end of 2011.Depuy synthes mitek quality engineering proposes that lot history reviews for legacy fms products be performed only in the event that a trend relating to a specific batch/lot has been identified.Also, since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions these batch reviews are not done.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa).
 
Event Description
It was reported by the customer that during an unspecified surgical procedure, it was observed that the 4580 fms duo+ pump/shaver combo device had poor suction.There was no delay in the surgical procedure as an identical spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key8284951
MDR Text Key134352416
Report Number1221934-2018-53277
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020607
UDI-Public10886705020607
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/12/2017
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 Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Initial Date Manufacturer Received 01/12/2017
Initial Date FDA Received01/29/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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