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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR CLPLSE90 ELECTRODE W HAND CNTRLS ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

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DEPUY MITEK LLC US VAPR CLPLSE90 ELECTRODE W HAND CNTRLS ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE Back to Search Results
Catalog Number 228147
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The complaint device is not being returned, therefore unavailable for a physical evaluation. A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. We cannot discern a root cause for the reported failure mode. A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. At this point in time, no corrective action is required and no further action is warranted. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the sales rep that three minutes into a shoulder arthroscopy surgical procedure, it was observed that the suction stopped working on the customer's vapr cool pulse 90 degree electrode with hand controls. Neptune was being used for suction. The case was completed by using another electrode. There were no patient consequences or delays. The sales rep stated that the device was discarded and not available to be returned. 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 NameVAPR CLPLSE90 ELECTRODE W HAND CNTRLS
Type of DeviceENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
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 Key8284987
MDR Text Key136614133
Report Number1221934-2018-53291
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number228147
Device Lot NumberU1608113
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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