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

Model Number 227204

Device Problems Suction Problem (2170); Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.(b)(4).The lot number is unknown at this time.

Event Description

It was reported by affiliate via complaint submission tool as follows: surgeon was using vapr premiere 90 in a shoulder arthroscopy.From the beginning he didn't feel there was much suction.They checked suction and it was working so they changed to new premiere 90 wand and everything worked fine.There was no harm to the patient.There was a surgical delay of 5 minutes.The device is available for evaluation.

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: d10, h3, h6: 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.

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: investigation summary
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> according to the information received, it was reported that the surgeon was using vapr premiere 90 in a shoulder arthroscopy.From the beginning he didn't feel there was much suction.They checked suction and it was working so they changed to w new premiere 90 wand and everything worked fine.The complaint device was received and evaluated.No visual damages observed in the device, sings of activation can be observed.Due to the failure reported is related to suction, the device will be sent to supplier for further evaluation.Supplier evaluation result for vapr coolpulse90 electrode: the device has not been returned in its original packaging, the active tip looks in an as expected used condition, there is visible tissue debris in the tip suction path, no residue can be seen in the suction tubing.The electrical test was performed with the different parameter (active continuity, return continuity, primary capacitance, and hipot active return), as a result all parameters passed.The device was functional testing, the test included different values as generator connection display, generator default values, minimum settings available, maximum settings available, available waveforms, flow rate, as a result the flow rate fail.Activation without suction: 1 minute ablate and 1 minute coagulation pass and the flow rate post-activation fail.Further investigation: a positive pressure test was performed on the device in an attempt to free the blockage.A combination of positive pressure and vacuum could not remove the blockage.A thin gauge wire was inserted into the suction path to locate the blockage.The blockage was located at the proximal end of the active suction tube.The blockage was caused by uv glue migrating into the suction path.Once this was removed, flow through the suction path was achieved.Supplier summary: the customer¿s claim of an issue with the device suction was substantiated.The investigation discovered that the proximal end of the active suction tube was blocked by uv glue.Once this was removed flow through the device was achieved.From our investigation we were able to confirm the reported suction failure.The complaint failure mode was confirmed as uv glue within the active suction tube and is consistent with other complaint devices investigated under a capa.These blockages were identified as uv glue migrating to these areas due to the uv glue not being cured enough to prevent movement to the suction path.The curing process would then be fully achieved with the application of radiation at the sterilizer.Further investigation into this failure is being conducted under a capa with process improvements under review.This failure is currently under investigation within capa.The following complaint will be added to the scope.A dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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
• MDR Report Key: 10800496
• MDR Text Key: 215047411
• Report Number: 1221934-2020-03353
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009626
• UDI-Public: 10886705009626
• Combination Product (y/n): N
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 02/16/2021
• Patient Sequence Number: 1