MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 4.0MM W/INTEGR HDP -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225370

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the vapr s90 4.0mm electrode with integrated handpiece worked and after 1 hour of use did not work.The device was received and evaluated.Visual inspection revealed that there is no visual damages in the device, the suction tube has no saline residues, the electrode tip has no sings of activation.The electrode was tested and presented failure on both modes.The electrode was sent to the manufacturer for further evaluation and testing.The apr 3.5mm side 21 deg -ea was evaluated by the supplier with the following results: the device was not returned in the original packaging.The distal tip shows no signs of obvious activation.Saline residue in suction tube.No visible damage to handle, cable or plug.The electrical test was performed; as a result, the return continuity and primary capacitance tests were passed, however, the active continuity and active return test failed.To investigate the active continuity failure, the handle was opened up and continuity checks performed to locate the breakdown in active continuity.It was found an issue in the zone of the electrical crimp.Functional testing was conducted using vapr vue generator (gml4854/2); and available settings were checked and passed, however the ablation and coagulation showed no output at tip.The customer claimed that the device did not work after an hour of use.The visual inspection did not highlight any signs of use on receipt.The investigation did confirm that the device would not activate on either mode.A break in continuity across the electrical crimp was discovered to be the fault.After 3 minutes of attempting to activate the device, no function was recorded.The continuity between the active plug pin and distal tip was re-measured and found to be still out specification.From our investigation we were able to confirm the customer reported defect, the returned device was found to exhibit intermittent connection in continuity across the electrical crimp contained within the handle.A manufacturing record evaluation was performed for the finished device [u1810104] number, and no non-conformance were identified.A capa investigation was initiated to investigate the intermittent connection within the device handle which resulted in a design activity to improve the robustness of the electrical connections.At this time, 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.

Event Description

It was reported by the customer in (b)(6) that during a arthroscopy rotator cuff repair procedure on (b)(6) 2019, it was observed that the vapr s90 4.0mm w/integr hdp -ea worked but stopped working after one hour of use.During in-house engineering evaluation, it was determined that the device failed the test for coagulation mode.Another like device was used to complete the procedure with a ten minute delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR S90 4.0MM W/INTEGR HDP -EA
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11388042
• MDR Text Key: 238606897
• Report Number: 1221934-2021-00671
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• Reporter Country Code: FP
• PMA/PMN Number: K120095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/25/2021

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 Date: 09/30/2021
• Device Model Number: 225370
• Device Catalogue Number: 225370
• Device Lot Number: U1810104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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