MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR ARCTIC SUCTION ELECT DOME; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated visually.The reported failure can be confirmed as the shaft of the device is bent 90 degrees near the distal end of the shaft.This device cannot be tested for its functionality due to the condition it was received in.It cannot be determined what caused this failure but based on the reported complaint, it is likely that there was excess force applied on the device by the end-user.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed (b)(4) similar complaint for this lot of devices that were released to distribution.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).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported that during the hip procedure, at the stage of the capsulotomy by using the electrode vapr arctic, the electrode tip broke off where there is the part that allows the device to move.The procedure was completed by using a new device.No consequences for the patient are reported.

• Brand Name: VAPR ARCTIC SUCTION ELECT DOME
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7796277
• Report Number: 1221934-2018-51008
• Device Sequence Number: 2335771
• Product Code: GEI
• UDI-Device Identifier: 10886705022526
• UDI-Public: 10886705022526
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2015

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
• Operator of Device: Health Professional
• Device Catalogue Number: 225029
• Device Lot Number: U1507085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2015
• Initial Report FDA Received Date: 08/19/2018
• Patient Sequence Number: 1