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

Model Number 225028

Device Problems Use of Device Problem (1670); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/16/2022

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 was in normal use condition.The cable was in good condition as well as the connector and pins.The suction tube showed saline residues.The active tip showed signs of activation.When connected to the test generator, the electrode was immediately recognized.When performing the functional test, the ablation and the coagulation functions were able to work.The electrode will be sent to the manufacturer for further analysis.Manufacturer evaluation result for vapr tripolar 90 suction elect: only one device returned.Device was not returned in the original packaging.The active tip is in a used condition with visible tissue debris in the suction ports.No visible damage to the device procedural debris visible in suction tube.The electrical test was performed, all parameters passed the test.Functional testing was conducted using vapr vue generator gml3723/4; the full test was passed.Manufacturer summary: the customer reported fault was that the device did not work during the procedure, this could not be confirmed during testing at olympus.Testing shows the returned device was immediately recognized and successfully passed electrical testing, functional testing, flow testing and activation performance remained consistent and we were unable to reproduce the reported issue.The complaint device was found to meet the manufacturers specification; therefore, no further investigation is possible.The root cause of the customer reported issue could not be determined.A dhr review has been performed for the complaint device lot number u1910111; 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 the customer in france that during an unknown surgery on (b)(6) 2022, it was observed that the vapr tripolar90 suction electrode did not work.During in-house engineering evaluation, it was determined that the suction tube showed saline residues.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: VAPR TRIPOLAR90 SUCTION ELECTRODE
• Type of Device: ENDOSCOPIC 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14715985
• MDR Text Key: 294529708
• Report Number: 1221934-2022-01819
• 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
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U1910111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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