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

Model Number 227204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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).Incomplete.The lot and expiration date is unknown at this time.

Event Description

It was reported that this was a manual shoulder stereoarthrolysis treating immovable shoulder joint on (b)(6) 2020.The postoperative event took place as follows: on (b)(6) the patient¿s arm was stabilized with the smith & nephew¿s spider 2 in the beach chair position during the procedure.Next, he underwent synovectomy and articular capsule release with the electrode (227204) and a shaver.Finally, the surgeon released the arm from the spider 2 and made sure that the arm had no difficulty with range of motion such as lateral rotation and abduction, etc.On (b)(6) the surgeon noticed that the patient had suffered from brachial plexus palsy.Currently the patient is hospitalized.The surgeon made the following comments: the electrode did not make contact with the nerve during the procedure.The use of the electrode was not necessarily the cause of the event.On the other hand, the intraoperative or postoperative arm¿s position might have been attributable to the event.Anyhow, any circumstances could not be ruled out of the possible cause.Severity of the brachial plexus palsy was evaluated as mild to moderate.Additional information provided by the affiliate reported medical intervention has not been taken for brachial plexus palsy and the patient is under medical follow-up.The range of motion is gradually better.

Manufacturer Narrative

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 is not being returned, therefore unavailable for a physical evaluation.It was mentioned that the intra-operative or postoperative arm¿s position might have been attributable to the event, therefore is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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: 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: 9986812
• MDR Text Key: 188650753
• Report Number: 1221934-2020-01223
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 04/28/2020
• Patient Sequence Number: 1