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 Codes	Arcing of Electrodes (2289); Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that after about 20 minutes from the start of asd during the arcr surgery, it was observed that there was a warning sound and the surgeon could not excise the tissue.When the surgeon pulled the instrument out from the operation field, there was a spark from the electrode while emitting a warning sound when the surgeon tapped the foot switch of cutting.There was no spark and warning sound when the surgeon tapped the foot switch of hemostat.The surgery was completed by using alternative probe (same p/n, but the lot# was unknown).It was brand new and the first use when the issue occurred.There was no surgical delay and no harm to the there was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.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 was received and evaluated.The suction tube was intact, and visual inspection revealed saline residue in the suction tube indicating the device was used.Visual inspection of the device revealed the active tip showed signs of activation and the manifold was melted at 5 o¿clock position of the tip.This complaint is confirmed.No functional test was conducted to avoid any further damage to the device and to test equipment.It was reported in the event description that there was a warning sound and then the device was pulled out.After pulling out, the device was inadvertently activated outside of the patient.The ifu specifies that ¿ensure that fluid inflow and outflow is adequate and that the electrode is activated only when surrounded by conductive irrigant solution (e.G., saline or ringer¿s lactate)¿.This device failure can be attributed to device misuse.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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: 7939062
• Report Number: 1221934-2018-54829
• Device Sequence Number: 2254953
• 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): 09/05/2018

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: 12/31/2020
• Device Catalogue Number: 225361
• Device Lot Number: U1801139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1