MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR HOOK W/ HAND CONTROLS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228305
Medical Device Problem Codes	Blocked Connection (2888); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional 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.H11 additional narrative: d4: the device expiration date was unknown in the initial report.The date of expiration has been updated accordingly.H4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.
Additional 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.H11 additional narrative: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (u2403017), and no non-conformance was identified.At this point in time, no corrective action is required, and 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.
Event or Problem Description
It was reported by the sales rep in germany that during an unspecified surgical procedure on an unknown date the customer's vapr no longer recognized this electrode and showed the error message ¿faulty instrument¿ on the display.According to the reporter the customer disconnected and reconnected the electrode during the operation and was able to continue operating until the error occurred again.It was reported that the electrode had to be disconnected and reconnected several times during the operation.There was no significant delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional 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.E3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional 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.H11 additional narrative: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (u2403017), and no non-conformance was identified.At this point in time, no corrective action is required, and 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.
Additional 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.H11 additional narrative: the products were returned to j&j medtech orthopaedics for evaluation.J&j medtech orthopaedics then conducted visual inspection of the devices received.Visual inspection revealed that seven new vapr hook w/ hand controls in its sealed packaging were returned for evaluation.The packages were opened and it was noted that none of the devices showed any structural abnormalities; shaft, handle, buttons, cable and plugs were in a normal condition.To test their functionality, the electrodes were connected to the vapr vue test generator, and they were recognized immediately, the default values were displayed correctly (hook, ablate power 120 and coagulate power 90), no alert messages were displayed.The ablation function was activated several times in its maximum power (maximum ablate power 180) for one minute each test, and they worked as intended.Under coagulation function, the electrodes were activated several times in its maximum power (maximum coagulate power 120) for one minute each test, and the coagulation function worked as expected, no anomalies could be identified in all devices, their activation was continuous.Also a test footswitch was used and both functions performed as intended.The overall complaint was unconfirmed as the observed condition of the seven vapr hook w/ hand controls would have not contribute to the complained devices issue.¿ based on the investigation findings and since all devices passed successfully visual and functional checks, it was conclude that there is no enough evidence to determine a root cause for the issue experienced by the customer.Therefore, it has been determined that no corrective and/or preventative action is required.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: VAPR HOOK W/ HAND CONTROLS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 20083239
• Report Number: 1221934-2024-02982
• Device Sequence Number: 7663621
• Product Code: GEI
• UDI-Device Identifier: 10886705020928
• UDI-Public: (01)10886705020928(10)U2403017(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 228305
• Device Lot Number: U2403017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 09/03/2024; 09/12/2024; 09/12/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/03/2024; 09/04/2024; 09/16/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown