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 05/09/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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 the unknown surgery, the device could not work continuously.No visual damages in the device, no saline residues were observed, no signs of activation can be observed, electrode was tested, and presented intermittence on both modes, the device will be sent to gyrus for further investigations.Supplier evaluation result for vapr s90 4.0mm w/integr hdp -ea: the device has not been returned in its original packaging.The active tip is in a used condition, with residue in suction tube.Also, it was not retained and could be removed.There are not visible damage to the device shaft, handle, cable or plug.The electrical test was performed; as a result, it was identified active continuity failure, the handle was opened, and continuity checks performed to locate the breakdown in active continuity.The device was connected to a vapr vue generator to test its functionality; therefore, it was performance of the device was further assessed by activating via the ablate yellow foot pedal for an extended period.The continuity between the active plug pin and distal tip was re-measured and found to be within specification.Supplier summary: the customer claimed that the device ¿could not work continuously.The investigation confirmed that initially the device would work but then stopped.Even after an extended period of 3 minutes the device would still no longer work.A break in continuity across the electrical crimp was discovered to be the fault.The continuity between the active plug pin and distal tip was to out of specification.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.The complaint device investigated was manufactured prior to this change.Dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.At this point in time, 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 that during the unknown surgery,the device could not work continuously.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10503198
• MDR Text Key: 206130752
• Report Number: 1221934-2020-02403
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120095
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 225370
• Device Catalogue Number: 225370
• Device Lot Number: U1903110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1