MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 2.3MM WEDGE 1-PIECE ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227203
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the healthcare professional in china that during an unspecified procedure on (b)(6) 2024, when using the vapr 2.3mm wedge 1-piece electrode device many bubbles were observed and it was found that the ceramic was broken.Another like device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi:(b)(4).Investigation summary: according to the information received, it was reported that during the surgery, when in use, noted many bubbles, and is was found the ceramic was broken(as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.The device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however the it is not possible to verify the broken condition of the ceramic insulator.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.The overall complaint was unconfirmed as the photographs attached are insufficient to draw a conclusion about the reported event.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes 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.
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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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.H10 additional narrative: the device was received and evaluated.Visual inspection revealed that the electrode is in used condition.The cable is in good condition as well as the connector and pins.The active tip shows signs of activation.The ceramic tip is not broken.When connected to the test generator, the electrode was immediately recognized.When activating the electrode, very small bubbles were coming out of the tip.The device will be sent to the manufacturer for further analisys.Manufacturer evaluation result for vapr 2.3mm wedge 1-piece electrode -ea: the device was received in shelf carton.Device is in used condition.No visible crack on ceramic.Handle assembly is in good condition.Cable and plug are in good condition.Electrical test: the device passed all the parameters.Functional test: the device passed all the checks.From our investigation we were unable to confirm either of the customer reported issue(s) "it was reported that during the surgery, when in use, noted many bubbles, and is was found the ceramic was broken." visual inspection shows the ceramic to be in an expected condition with no defects, cracks or structural anomalies being observed.Activation of the electrode did not reveal any anomalies with the degree of bubble creation being as expected.Testing at atl uk shows the returned device was immediately recognized and found to pass both electrical and functional testing, with no abnormal bubble creation or any other issue being detected.Activation was found to be consistent and as expected.The returned complaint device was found to meet the manufacturers specification; therefore, no further investigation is possible regarding the returned complaint device.Conclusion: no fault found - the root cause of the customer reported issues(s) could not be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes 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 2.3MM WEDGE 1-PIECE ELECTRODE -EA
• Common Device Name: 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 ; 3035526892
• MDR Report Key: 18844467
• Report Number: 1221934-2024-00681
• Device Sequence Number: 7832773
• Product Code: GEI
• UDI-Device Identifier: 10886705009619
• UDI-Public: 10886705009619
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082643
• 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
• Report Date (Section B): 03/06/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 227203
• Device Lot Number: U2302084
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/25/2024; 05/06/2024; 05/07/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/02/2024; 05/07/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown