MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR2.3MM SIDE SHRT 1-PCE ELECTRODE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 227211

Device Problem Blocked Connection (2888)

Patient Problem Not Applicable (3189)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.Udi: (b)(4).

Event Description

It was reported that this was an arthroscopic synovectomy in the elbow on (b)(6) 2020.The var vue main unit did not recognize the electrode.The procedure was delayed less than 30 minutes.There was no harm to the patient.The devices were brand new and the first use when the issue occurred.Additional information provided by the affiliate reported the device will not be returning 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: investigation summary: according to the information provided, it was reported that the var vue generator did not recognize the electrode.The complaint devices were not returned, therefore unavailable for a physical evaluation.Since the complaint devices were not returned, we cannot determine a root cause for the reported failure.If the devices are received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [u1907124] number, and no non-conformances were identified.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.

• Brand Name: VAPR2.3MM SIDE SHRT 1-PCE 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: 10708427
• MDR Text Key: 212367366
• Report Number: 1221934-2020-03097
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009633
• UDI-Public: 10886705009633
• Combination Product (y/n): N
• PMA/PMN Number: K082643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 227211
• Device Catalogue Number: 227211
• Device Lot Number: U1907124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Patient Sequence Number: 1