MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR 90 SUCTION ELECT; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225028

Device Problems Break (1069); Contamination /Decontamination Problem (2895); Suction Failure (4039)

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

Event Date 02/17/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in (b)(4) that during an unknown surgery on an unknown date, it was observed that the vapr tripolar 90 suction electrode device had presence of bubbles in the tubing.During in-house engineering evaluation, it was determined that the suction tube on the device showed saline and biological residues.It was further determined that the further investigational work confirmed the flow restriction to be at both the control valve and distal end of the device and was caused by procedural debris.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: visual inspection revealed that the cable was in good condition as well as the connector and pins.The suction tube showed saline and biological residues.The electrode tip showed signs of activation.When performing the functional test, the electrode was connected to the vapr vue test generator, the ablation function was activated for one minute, the electrode worked as intended.Under coagulation function, the electrode was activated for one minute and the electrode worked as intended.For the suction testing, the electrode was sent to the manufacturer for further evaluation.The vapr tripolar 90 suction elect was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection of the device was performed, as a result, the device was returned in the original packaging.The active tip was in a used condition with visible deposits on the face of the active tip and tissue debris in the suction ports; finally, no visible damage to the device.The device passed all other electrical and functional testing.The flow testing recorded a flow value below the minimum specification.Further investigational work confirmed the flow restriction to be at both the control valve and distal end of the device and was caused by procedural debris.A dhr review has been performed for the complaint device lot number u2109048; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the investigation findings and ra review no correction action has been implemented.From our investigation we were able to confirm that the electrode suction was blocked by procedural debris when evaluating the returned device.The device was found to fail flow test specifications due to tissue debris within the suction path at the distal end of the device which could not be removed during the investigation.The purpose of the suction function is to assist in the removal of bubbles and debris created during activation within the operating site.If the suction flow becomes blocked and the blockage unnoticed by the user then the extraction of bubbles and debris is either severely restricted (partial blockage) or non existent (total blockage).The product ifu cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: VAPR TRIPOLAR 90 SUCTION ELECT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14457246
• MDR Text Key: 292389656
• Report Number: 1221934-2022-01481
• 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,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: U2109048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Date Device Manufactured: 10/01/2021
• 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