MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM SIDE 21 DEG -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 225302

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005)

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

Event Date 11/22/2023

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.H10 additional narrative: e3: reporter is a j&j employee.D10: concomitant med products and therapy dates: handpiece device, (b)(6) 2023 h4: the device manufacture date is currently unavailable.Investigation summary
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> the vapr 3.5mm side 21 deg -ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection and functional test of the device were performed, as a result; it shows the tip component in good condition, some evidence of residue around the coil of the active tip.The handle assembly were also in good condition.Evidence of connection to the handpiece was found.The device fails in the active continuity check.The device passed the following functional test; generator connection display, generator default values, minimum settings available, maximum settings available, available waveforms however it failed the footswitch activation, no activation in either ablate or coagulation modes.From our investigation we were unable to confirm the customer reported fault that an error message "insert electrode" was displayed, however a fault was confirmed with the complaint device as it failed electrical testing, based on this the overall complaint was confirmed.Further investigation found that the contact pad had been damaged which has resulted a failed electrical connection between the solder joint and pcb.As detailed in the product control plan this product is 100% electrically tested at process id 135 - check continuity active & return as part of its product test regime, therefore if this damage was present during the manufacturing process the complaint device would have failed electrical testing and been rejected.The damage seen which has caused the electrical failure has occurred post manufacture, it is not known where or how this damage has occurred.The root cause of the customer reported failure could not be determined.The failure mode has been reviewed against the systems risk assessment document, the highest identified risk within, for failure modes that are equivalent to the complaint failure mode is system units\system unit features do not function\stop functioning during use, line 1100 applies.Resulting in increased procedure time patient under anesthetic extended period of time.The severity risk category is 'minor (- results in temporary injury or impairment not requiring professional medical attention.For this scenario a pre mitigation risk of grid and a post mitigation risk of grid are stated, which is 'minor' and 'probable' and rated as low as reasonably achievable (alra).A dhr review has been performed for the complaint device lot number u2208010; 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 risk documentation no correction action has been implemented.Based on the investigation findings, it has been determined that 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.Udi: (b)(4).

Event Description

It was reported by the affiliate in japan that during a arthroscopic rotator cuff repair for a rotator cuff tear procedure, it was observed that although the electrode on the vapr angled side effect electrode 3.5 mm x 160 mm device was connected to a handpiece device with the proper order and method, an error message ¿insert electrode¿ was shown, and the electrode was not able to be used.When another probe was connected to the handpiece, the probe worked as expected.During in-house engineering evaluation, it was determined that the device would not coagulate.Another like device was used to complete the procedure.The surgery was completed successfully with a 30-minute delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR 3.5MM SIDE 21 DEG -EA
• 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: 18905781
• MDR Text Key: 337690693
• Report Number: 1221934-2024-00850
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225302
• Device Lot Number: U2208010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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