MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE 90 ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 227204

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Residue After Decontamination (2325)

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

Event Date 07/29/2022

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 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).The complaint device was received and evaluated in juarez laboratory.Visual inspection revealed that the tip showed signs of activation and saline residues in the suction tube.The cable is in good condition as well as the connector and pins.When performing the functional test, the electrode was connected to the vapr vue test generator, an output shorted error showed during ablate, the coagulation was activated.The electrode was sent to the manufacturer for further evaluation.The vapr premiere 90 electrode -ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.Upon visual inspection of the device, the device has not been returned in its original packaging, the active tip is in a used condition; also, there is tissue debris visible in the active suction port and there is a saline residue visible in the suction tubing.The testing found that the device failed the hipot test and during the activation tests an ¿output short¿ error appeared on the generator when the ablate and coag modes were activated.Dhr review has been performed for the complaint device lot number u2105038; 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.From our investigation we were able to confirm the customer reported issue.The device failed functional testing displaying an output shorted error caused by an insufficient glue coverage between active tip and active suction assembly.The failure mode seen has been caused by is consistent with previous complaint devices investigated under capa where actions were already implemented to help prevent recurrence of this issue are detailed below: update of the assembly aids and dn0012950 to further emphasize critical gluing process, to add image in appendix to highlight critical gluing instructions and add this to gluing station as visual aid.Additionally, training videos were embedded into assy aids to further support gluing processes in-line with best practice assembly method.Retraining of all operators that are completing id60 within cr1 and cr2 against assembly aid 588060 & dn0012950.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.

Event Description

This is report 2 of 2 for (b)(4).It was reported by the distributor in slovakia that during a knee arthroscopy procedure on (b)(6) 2022, it was observed that the vapr side effect electrode 3.5mm, side effect w/integrated handpiece device did not work.During in-house engineering evaluation, it was determined that the device had tissue debris visible in the active suction port and saline residue visible in the suction tubing.It was further determined that the device failed the hipot test and during the activation tests an ¿output short¿ error appeared on the generator when the ablate and coagulation modes were activated.There were no adverse patient consequences nor surgical delay reported.

• Brand Name: VAPR PREMIERE 90 ELECTRODE -EA
• 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: 15674833
• MDR Text Key: 306738970
• Report Number: 1221934-2022-03303
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: 10886705009626
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 227204
• Device Catalogue Number: 227204
• Device Lot Number: U2105038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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