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

Catalog Number 227204

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the customer's truespan peek 12 degree would not fire the first implant.Also, during the same case the customer's vapr premiere 90 electrode would not ablate and was not suctioning.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.The devices will be returning for evaluation.

Manufacturer Narrative

(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the complaint device was received and evaluated.The active tip looks in an as expected used condition.Tissue debris is visible in the tip suction path as well as residue evident in the suction tubing.The device was sent to the manufacturer for further evaluation.The manufacturer reported the following: the customer¿s claim of the device not working on ablate mode and the suction not working was substantiated.The investigation established that there was a blockage in the suction path caused by tissue debris at the tip.Once this was removed a within specification flow value was achieved.The activation tests found that an output error would occur when the device was activated on both ablate and coag modes.The cause was found to be a leakage path between the active and return paths at the tip of the device.This can be triggered by an incomplete adhesive seal, resulting in an ineffective isolation of the active and return.We were able to confirm the reported suction issue with the returned electrode however no manufacturing defect was found and we have determined the cause of the reported suction blockage to be normal procedural debris within the active tip which was successfully cleared using positive pressure and vacuum.The product ifu cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.A dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the product dhr, quality data and ra no corrective action is deemed necessary at this moment in time.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

• 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: 9406498
• MDR Text Key: 203531866
• Report Number: 1221934-2019-59826
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

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 Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 227204
• Device Lot Number: U1904129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 01/17/2020
• Supplement Dates FDA Received: 12/23/2019; 01/17/2020
• Patient Sequence Number: 1