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	Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The affiliate reported via email that there was an abnormal spark scattered during arthroscopic rotator cuff repair surgery on (b)(6) 2017.It was brand new and the first use when the issue occurred.There was no surgical delay and no harm to the patient.The backup device was used to complete the case.Additional information received via email from the affiliate on 10-24-2017.The issue was detected during the surgery: no information is available if the electrode sparked inside the patient.No information is available how long the electrode used prior to the spark.No information is available if anything fell in the patient.There was no delay.The procedure was able to be completed.There was no patient impact.
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 is not available for physical evaluation, hence, the complaint cannot be confirmed.A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.No further information regarding the technique used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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 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: 7539797
• Report Number: 1221934-2018-50797
• Device Sequence Number: 2512900
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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: 09/30/2019
• Device Catalogue Number: 225361
• Device Lot Number: U1610060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1