MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 225024

Device Problems Environmental Particulates (2930); Output Problem (3005)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.E3: reporter is a j&j sales representative.Udi: (b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep in australia that during a rotator cuff repair surgical procedure performed on an unknown date in (b)(6) 2024.It was observed that vapr vue generator wand stopped working.It was reported that after troubleshooting the problem, an electronic burnt smell was emitted from the vapr unit.It was reported that the wand was swapped with same outcome.It was reported that the machine was replaced, and case continued.It was reported that there was a 4 minute delay in the procedure due to the event, and the procedure was successfully completed.There was no harm to the patient.No further information is available.

Event Description

This is report 1 of 2 for (b)(4).It was reported by a healthcare professional in australia that during a rotator cuff repair surgical procedure on an unknown date in (b)(6) 2024, it was observed that the an unknown electrode device and a vapr vue generator device stopped working while in use together.According to the report, after troubleshooting the problem, an electronic burnt smell was emitted from the generator.It was reported that the electrode was swapped but with same outcome.It was reported that the generator was replaced to complete the surgery successfully with a delay of four minutes.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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 at the service center and evaluated.During the service evaluation the following defects were identified: ¿ functional : electrical/electronic component failure.Per service reports, this complaint can be confirmed.The device was scrapped as system is non-repairable.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Device history review
=
> a manufacturing record evaluation was performed for the finished device serial number, and no non-conformances were identified.

• Brand Name: VAPR VUE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18574727
• MDR Text Key: 333634795
• Report Number: 1221934-2024-00272
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009121
• UDI-Public: 10886705009121
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1