MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE50 ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 227504

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that during a rotator cuff repair, when connecting a premiere 50 electrode to generator it did not function at all, and screen did not show any alert code.The complaint device was received and evaluated.Visual inspections revealed no visual damages in the device, no salines residues were observed, no signs of activation can be observed.The electrode was tested and presented failures on both modes.The device will be send to gyrus for further investigations.Supplier evaluation result for vapr premiere50 electrode -ea: the device has not been returned in its original packaging, the active tip of the electrode shows no clear signs of activation, saline residue in the suction tube, the electrode shaft, handle, cable and plug does not show any signs of damage.The electrical test was performed with the different parameters as a result active continuity test fail, the remaining test passed.The device was functional testing, the test included different values as a setting and the activation in ablate and coagulation were failed.Supplier summary: the device as presented showed no active continuity.The break in continuity was located across the electrical crimp.The activation test recorded that initially there was no activation at the tip on either mode.After seconds the device began to consistently operate.Following activation, the continuity was remeasured and found to be within 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 cap 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.Dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.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).

Event Description

It was reported by sales rep via complaint submission tool that during a rotator cuff repair, when connecting a premiere50 electrode to generator it did not function at all, and screen did not show any alert code.They changed to another electrode and same happened.Another device was used to complete procedure.Only one device will be returned, the other was discarded by hospital.No surgical delay or patient consequences reported.No additional information could be provided.

• Brand Name: VAPR PREMIERE50 ELECTRODE -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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10605059
• MDR Text Key: 209139858
• Report Number: 1221934-2020-02808
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009923
• UDI-Public: 10886705009923
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 227504
• Device Catalogue Number: 227504
• Device Lot Number: U1901048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1