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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 Problems Crack (1135); Increase in Pressure (1491)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Reporter is company employee. Investigation summary:the device was received and evaluated at the service center. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. It was found that the right cover of the device was cracked. Also the right roller pump head was damaged and the over pressure was out of tolerance. The device was found to not be calibrated correctly. A mechanical upgrade was performed, pressure mechanism re-adjusted, and the irreparable cover, the defective pump roller, and the color coding for tube set were replaced. The device was cleaned, newly calibrated, repaired and found to be fully functional. The incorrect calibration of the device may have caused the over-pressure to go out of tolerance. Also the cracked cover is most likely a result of user mishandling of the device. However, given the information provided we cannot discern a definitive root cause for the other identified failures. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on 06/18/2018 and passed all functional testing before being returned to the customer. At this point in time, no corrective action is required, and no further action is warranted. Depuy 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. Udi: (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during service assessment 4580 fms duo+ pump/shaver combo device was identified as defective. No reported malfunction from the customer, no patient involvement, and no surgical delay. The failure was detected during electrical safety test. This is report 1 of 1 for complaint(b)(4).
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of DeviceDISTENSION 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
6103142063
MDR Report Key9256990
MDR Text Key207211798
Report Number1221934-2019-59343
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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