MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	228504
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device received.Investigation summary: the device was received and evaluated.The complaint can be confirmed.It was observed that the active tip of the device appeared activated and saline residue was present in the suction tubing indicating that the device had been previously used.The device was connected to a test generator to test the functionality of the device.The device was activated in both ablate and coagulate modes for several seconds, and there was no output.The device was forwarded to the manufacturer for further investigation into the observed failures.The manufacturer indicated that the active continuity of the device was out of specification.The handle of the devices was opened to further investigate the electrical defects.There was an breakdown in active continuity across the electrical crimp.There was no output on ablate and coag modes.A manufacturing record evaluation was performed for the finished device lot numbers and product code, and no non-conformances were identified.At this point, 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.Device history report: device history lot a manufacturing record evaluation was performed for the finished device lot numbers and product code, and no non-conformances were identified.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).
Event or Problem Description
Device report from synthes mitek reports an event in (b)(6) as follows: it was reported by the affiliate via phone that during a knee arthroscopy cleaning the vapr p50 w/ hand controls does not function.The packing of the device was opened, connect the generator, does not show any error code, but did not work.Changed another two devices, the event re-happened.Another device was used to complete the surgery.There were no adverse consequences to the patient.The surgery time was not delayed.No additional information could be provided.This complaint is for one (1) vapr premiere 50 electrode w/hand controls, 3.0mm, 50° suction w/integrated handpiece.This report is 2 of 2 for (b)(4).

• Brand Name: VAPR PREMIERE50 ELECTRODE W/HAND CONTROLS
• 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: 9200557
• Report Number: 1221934-2019-59060
• Device Sequence Number: 3107155
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: (01)10886705020942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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: 02/29/2020
• Device Model Number: 228504
• Device Catalogue Number: 228504
• Device Lot Number: U1703011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1