MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 4.0MM SUCT LOPROFILE -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225361
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.Udi: (b)(4) ¿ incomplete.The expiration date is not currently available.
Event or Problem Description
It was reported by our affiliate that an output failure occurred with the reported device during rotator cuff repair surgery on (b)(6) 2018.A metallic sound gave off about 15 minutes after the operation was started.When taken a look at carefully, it was found that the electric detector of the prove seemed to be burned.It was brand new and the first use when the issue occurred.There was no delay in surgery and no harm to the patient.
Additional 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.Investigation summary: the complaint device was received and evaluated.Visual observation of the active tip indicates signs of activation and melted manifold between 3 - 6 o'clock position, confirming this complaint.No functional test was conducted to avoid further damage to the device and to test equipment.The dhr review indicated that the devices were processed without incident therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed one similar complaint for this lot of devices released to distribution.The supplier completed a capa investigation to address this failure.The root cause has been identified as small gaps or low application of the epotek adhesive creating a weak dielectric barrier between the active tip and the surrounding ceramic head, resulting in the failure of melting/burnt ceramic head material.Training requirements were updated to be performed on a six-month basis.This issue was also investigated via mitek dr.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 to monitor the extent to which this complaint is observed in the field.Udi: (b)(4).

• Brand Name: VAPR 4.0MM SUCT LOPROFILE -EA
• 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: 7702608
• Report Number: 1221934-2018-53978
• Device Sequence Number: 19015674
• Product Code: GEI
• UDI-Device Identifier: 10886705009381
• UDI-Public: 10886705009381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 225361
• Device Lot Number: U1705150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1