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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
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DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE Back to Search Results
Model Number 228146
Device Problems Infusion or Flow Problem (2964); Suction Failure (4039)
Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint#: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:(b)(4).
 
Event Description
It was reported by affiliate via complaint submission tool that during a shoulder arthroscopy, 3x times vapr coolpulse 90 electrode (228146) plugged in the vapr vue generator, 3x times the vapr electrode worked (yellow and blue buttons on the food panel keep the system running), but 3 times (all 3 vapr electrode) the suction was blocked, 3 times no water suction was possible, 3 times lot u2002104.We open a new vapr coolpulse 90 with another lot ,then everything was fine, no patient consequences.There was a surgical delay reported of 5 minutes.The devices are available for evaluation.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A manufacturing record evaluation was performed for the finished device [u2002104] number, and no non-conformances were identified.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : according to the information provided, it was reported that during a shoulder arthroscopy, 3x times vapr coolpulse 90 electrode (228146) plugged in the vapr vue generator, 3x times the vapr electrode worked (yellow and blue buttons on the food panel keep the system running), but 3 times (all 3 vapr electrode) the suction was blocked, 3 times no water suction was possible, 3 times lot u2002104.The device belonging to complaint pc (b)(4) / pi (b)(4) was received in mitek lab on 10/15/2020 and visual inspection and functionality test were performed; the visual inspections revealed that the 3 devices were not been returned in its original packaging.The active tip of the electrode show signs of activation, saline residues were observed; also, the electrode shaft, handle, cable, and plug does not show any signs of damage.Electrodes was connected in the generator and both modes were passed.The devices was sent to supplier for suction test.To continue with the product analysis, device was sent to cardiff uk for further analysis with manufacturing on date 11/20/2020 along with other product complaint devices with a total of 3 boxes, under fedex tracking# 8144 1121 9630.Logistics department informed that the material was not received in uk and it was returned to el paso.Tx, warehouse.Another shipment was conducted to send the boxes to uk for analysis under 400 109 6528 via ups and manufacturing department confirmed that only one box was received, it doesn¿t contain the product reported in this complaint.A manufacturing record evaluation was performed for the finished device [u2002104] number, and no non-conformances were identified.After multiple attempts to localize the devices locally in el paso, tx.Warehouse.Logistics department confirmed that the missing 2 boxes were not in their facility.Even though it¿s not possible to perform an actual evaluation on the device we have evidence from the visual inspection and production records that the device was manufactured in accordance with documented specification and procedures which indicates that the failure reported by the costumer is unlikely to be related to the manufacturing process.With the information available at the moment, this complaint cannot be confirmed.If the device is located in the future.This complaint will be reopened, and analysis will be performed accordingly.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.
 
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Brand Name
VAPR COOLPULSE90 ELECTRODE
Type of Device
ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10692657
MDR Text Key211758621
Report Number1221934-2020-03036
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10886705010080
UDI-Public10886705010080
Combination Product (y/n)N
PMA/PMN Number
K113545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/31/2023
Device Model Number228146
Device Catalogue Number228146
Device Lot NumberU2002104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Date Manufacturer Received03/21/2021
Patient Sequence Number1
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