MAUDE Adverse Event Report: DEPUY MITEK LLC US ANGLED SIDE EFFECT ELECTRODE, 21º; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225302

Device Problems Electrical /Electronic Property Problem (1198); Device Contamination with Body Fluid (2317); Power Problem (3010)

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

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in japan that during an unknown procedure (b)(6) 2022, it was observed that the angled side effect electrode, 21º device did not start when it was switched on.During in-house engineering evaluation, it was determined that the device had tissue debris visible at its distal end and failed the coagulation testing.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.The device was brand new and the first use when the issue occurred.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: the device was received and evaluated.Visual inspection revealed that the electrode is in normal condition, any anomalies on the device could be observed.Since the electrode arrived without its connector and cable, the functional test could not be performed.The electrode was sent to the manufacturer for further evaluation and testing.Manufacturer evaluation result for vapr 3.5mm side 21 deg -ea: device not returned in the original packaging.No handpiece returned.Tissue debris visible at the distal end the solder is missing from the active wire/pcb connection.The electrical test was performed, as a result, the continuity active failed.Functional testing was conducted, the device was connected to vapr vue generator gml3723/4; the activation, ablate and coagulation test failed.Manufacturer summary: during our investigation we have been able to confirm an electrical fault.The root cause of the defect can be assigned to a manufacturing defect due to an inadequate solder bond being applied during manufacturing at process id 110 fit and solder pcb as per assy aid (b)(4) causing an intermittent connection - human error.It is likely the poor solder bound was making an intermittent contact during the manufacturing process which allowed the device to pass electrical testing at process id 135 and then deteriorated further during transportation.The assignable root cause relating to this complaint is the manufacturing process.A capa investigation has already been completed to further investigate similar failure modes seen through complaints (b)(4).A correction action from this capa was the retraining operators within cr1 against the current assembly aid (b)(4) process id 110 fit and solder pcb which should help prevent recurrence of this defect.The customer's device was manufactured in march 2021 which was prior to this correction.In addition to the retaining preformed as part of continuous improvement the assembly aid has now been updated with an improved method of soldering which will allow the continued best practice for this soldering process.A dhr review has been performed for the complaint device lot number u2102117; no issues (ncrs or deviations) with the manufacturing process have been indicated at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: ANGLED SIDE EFFECT ELECTRODE, 21º
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• 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: 14853295
• MDR Text Key: 303228868
• Report Number: 1221934-2022-01905
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009268
• UDI-Public: 10886705009268
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 225302
• Device Catalogue Number: 225302
• Device Lot Number: U2102117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1