MAUDE Adverse Event Report: DEPUY MITEK LLC US S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	227355
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(6) that during an arthroscopic shoulder stabilization surgery on (b)(6) 2021, it was observed that the s50 sm.Dia.Electrode w/integ.Hndpiece device would not coagulate.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Udi: (b)(4).The expiration 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.H10 additional narrative: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.H10 correction narrative: d4: the lot number has been updated to reflect the correct information.Therefore, udi: (b)(4).
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 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.
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 additinal narrative: investigation summary = > the complaint device was received and evaluated.Visual inspection revealed that the electrode was in normal condition, any anomalies on the device could be observed.The cable was in good condition as well as the connector and pins.The suction tube showed saline residues.The electrode tip showed signs of activation.Electrode was tested, an "output shorted "error appeared during ablation and coagulate mode.Therefore, the device was sent to supplier for further evaluation.The s50 sm.Dia.Electrode w/integ.Hndpiece-ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection of the device was performed; as a result, the device has not been returned in its original packaging.No clear evidence of activation at tip.Residue visible in suction tube and on device handle.Finally, no visible damage to the device shaft, handle, cable or plug.No anomalies were found during electrical test.The device function would vary between correct performance and output short error.The different positions would vary the amount of energy being applied to the tip by the generator.It is thought the higher energy levels is bridging a gap between the active and return circuits.The customer¿s device was manufactured in august 2020.A dhr review has been performed for the complaint device lot number u2008016; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the investigation findings and product ra no containment or correction action related to the individual complaint is required.The failure mode seen was consistent with previous complaint devices investigated under capa caused by an insufficient amount of glue dispensed between the active shaft and the ceramic resulting in leakage path for saline ingress.As detailed in control plan 921110, all tripolar 90 electrodes are 100% inspected for leaks as part of their product test regime on cell 5 automatic tester (process id 500.19 and 500.20) therefore all reasonable containment already established is still in place.A nc was opened to track this failure with the supplier.At this point in time, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: S50 SM.DIA.ELECTRODE W/INTEG.HNDPIECE-EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13207279
• Report Number: 1221934-2022-00107
• Device Sequence Number: 4744776
• Product Code: GEI
• UDI-Device Identifier: 10886705009732
• UDI-Public: 10886705009732
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility,Company Representative
• Initial 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 227355
• Device Catalogue Number: 227355
• Device Lot Number: U2008016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 01/26/2022; 01/31/2022; 04/25/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/26/2022; 02/01/2022; 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown