MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR90 SUCTION ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 225028

Device Problems Device Contaminated During Manufacture or Shipping (2969); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary : the device was received and evaluated.Visual inspection revealed that the electrode is in normal use condition.The cable is in good condition as well as the connector and pins.The suction tube shows saline residues.The active tip shows signs of activation.The rubber button cover is out of its place and the electronics are exposed.The functional test can not be performed due to the button cover condition.The electrode will be sent to the manufacturer for further analysis.Manufacturer evaluation result for vapr tripolar 90 suction elect: the device was not returned in the original packaging.The active tip has some evidence of activation and there are some possible tissue residues inside one of the central suction holes.There is evidence of dried out blood or saline in the suction tube.The heatshrink, cable and plug look in good condition.The finger switch boot is misplaced.Electrical test: all parameters passed the test.Functional test was performed using vapr vue generator gml4808/3.The device was activated via foot switch since the rubber boot was misplaced.All parameters passed the test.The device as presented passed all electrical and functional checks.The finger switch cover boot is misplaced but it is not known how this occurred.Manufacturer summary: from our investigation we were unable to confirm the customer reported issue that the tip of the vapr became unsuitable during the intervention.Visual observations show the active tip has some evidence of activation and there are some possible tissue residues inside one of the central suction holes.Both the active tip and return cap were found to be in place and we could not detect any signs of damage or abnormality with the structure of the active tip or return cap.The rubber switch boot cover was found to be dislodged from its original position however it is not known how and where this has happened.There is no detail in the event information relating to the switch boot.It is possible that additional force/loading/stressing during use could be a factor if applied to the device during use, dislodging the rubber switch boot from its intended position or the the switch boot may have been dislodged post surgery during transportation.Testing at gyrus medical shows the returned tripolar device was immediately recognized when connected to a generator and found to pass both electrical and functional testing, with the exception of the dislodged switch boot, the complaint device was found to meet the manufacturers specification; therefore based on the event information received and the device presented no further investigation is possible.The root cause of the customer reported problem could not be determined.A dhr review has been performed for lot u2206093; no issues (ncrs or deviations) with the manufacturing process have been indicated at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by a healthcare professional in france that during an unknown procedure on an unknown date, it was observed that the tip on the vapr tripolar90 suction electrode device became unsuitable.During in-house engineering evaluation, it was determined that the active tip had some evidence of activation and there were some possible tissue residues inside one of the central suction holes; and therefore, there was evidence of dried out blood or saline in the suction tube.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: VAPR TRIPOLAR90 SUCTION ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17300344
• MDR Text Key: 319704419
• Report Number: 1221934-2023-02672
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: 10886705023103
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U2206093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1