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 Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(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.

Event Description

It was reported by the affiliate via email that the vapr s90 4.0mm w/integr hdp does not work.It was reported by the affiliate in (b)(6) that during arthroscopic surgical procedure of the shoulder, it was observed that the vapr s90 4.0mm w/integr hdp device did not work.During in-house engineering evaluation, it was determined that the device had no output; and that it did not coagulate nor ablate.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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 by the affiliate via email that the vapr s90 4.0mm w/integr hdp does not work.Saline residue in tube, no anomalies on the device, no output (no coag or ablate).Return to gyrus for further analysis supplier evaluation result for vapr s90 4.0mm w/integr hdp: device was not returned in the original packaging, distal tip shows no signs of activation, no clear and visible damage noted, with the active tip of the device in an out of box condition.Closer inspection does show some signs of use, with what appears to be dried saline.The suction tube of the device shows traces of dried saline within, however, no visible debris or blockage visible, the tyvek cover has been returned with the electrode, this confirms the devices` identification and lot number, the device has also been returned with the clamp valve in the ¿open¿ position, no visible damage to handle, cable or plug.The electrical test was performed with the different parameter (active continuity, return continuity, primary capacitance, and hipot active-return), as a result active continuity test fail, the remaining test passed.To investigate the active continuity failure, the handle was opened up and continuity checks performed to locate the breakdown in active continuity, some measurements zones were performed:plug to proximal end of crimp as result pass, across electrical crimp as result fail, distal end of crimp to active tip as result pass.The device was functional testing using vaprvue generator, the test included different values as a setting and the activation in ablate and coagulation failed.Supplier summary: the investigation substantiated the customer¿s claim that the ¿device did not work.A break in continuity across the electrical crimp was discovered.During the functional tests no activation at the distal tip was observed on either ablate or coag mode.After a period of 3 minutes pressing the ablate foot pedal the device still would not activate.The continuity between the plug pin and distal tip was re-measured and found to have increased further out of 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 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.A manufacturing record evaluation was performed for the finished device [u1812070] number, and no non-conformances were identified at this point, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• 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
• MDR Report Key: 9520814
• MDR Text Key: 198703379
• Report Number: 1221934-2019-60140
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• PMA/PMN Number: K120095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: U1810103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1