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 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.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 in (b)(6) that during anterior cruciate ligament (acl) reconstruction, it was observed that the vapr s90 4.0mm w/integr hdp -ea device did not work when connected with generator.According to the report, the device would not cut and would not coagulate.It was reported that no alert code showed in the screen.Another device was used to complete the surgery.There were no adverse consequences to the patient.After surgery, the customer tested the device again but still would not work and without any alert code showed in screen.It was not reported if there was a 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: the complaint device was received and evaluated.Visual observation reveals the distal tip shows signs of activation, no saline residue evident in suction and no visible damage to handle or plug.The device was sent to the manufacturer for further evaluation.The manufacturer reported the following: the investigation substantiated the customer¿s claim that the device did not function.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 footpedal the device still would not activate.The continuity between the plug pin and distal tip was re-measured and found to have reduced but was still 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 dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Furthermore, capa investigation has identified the components used in the process are not compatible for this method of joining and further design activity is required to improve the robustness of the electrical connections.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).

• 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: 9349529
• MDR Text Key: 207552460
• Report Number: 1221934-2019-59638
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

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: 11/30/2021
• Device Model Number: 225370
• Device Catalogue Number: 225370
• Device Lot Number: U1812011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1