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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK VAPR TRIPOLAR90 SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

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DEPUY MITEK VAPR TRIPOLAR90 SUCTION ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE Back to Search Results
Catalog Number 225028
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2017
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
The affiliate reported via email during a shoulder arthroscopy, according to the surgeon the suction did not work very well and eventually the suction did not work at all.A few minutes delay to open a second device.Not impact on patient.Additional information received via email from the affiliate on 10-16-2017 there was a resulting surgical delay of a few minutes only.Exact time delay unknown.No impact to patient.
 
Manufacturer Narrative
The complaint device was discarded and is not available for physical evaluation.The reported complaint cannot be confirmed and a root cause the reported device failure cannot be determined.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 records reviewed.Review of the depuy synthes mitek complaints system revealed one other dissimilar complaint for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).
 
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Brand Name
VAPR TRIPOLAR90 SUCTION ELECTRODE
Type of Device
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key7154786
MDR Text Key96233624
Report Number1221934-2017-10725
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/27/2017
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 Expiration Date05/31/2018
Device Catalogue Number225028
Device Lot NumberU1703050
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/27/2017
Initial Date FDA Received12/29/2017
Supplement Dates Manufacturer Received01/17/2018
Supplement Dates FDA Received01/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2017
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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