MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM SIDE STR -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225301
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
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.Udi: (b)(4).The expiration date is currently unavailable.Investigation summary: according to the information received, it was reported that during an arcr treating rotator cuff tear, the electrode did not start when it was connected to a handpiece.The device was brand new and the first use when the issue occurred.The device was received and evaluated in juarez laboratory.Visual inspection revealed that signs of activation on the active tip and stains were observed on blue handle.The vapr hand piece used was not received for evaluation.The device was sent to the manufacturer for further testing.The vapr 3.5mm side str -ea was returned to manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of device received by customer.The visual inspection revealed that the device was not returned in its original packaging.Also, the device looked in a generally good state.The active tip looked unused but there was a residue around the active tip and ceramic.The electrical contacts looked like they have been attached to a handpiece.There were some stains on the handle area.The electrical test was performed; as a result, the capacitance failed.The device was connected to vapr vue generator gml4808/4 however the device was not recognized.Multiple attempts to connect did not affect this result.A dhr review has been performed; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Therefore, no containment or correction action related to the individual complaints is required.The customer¿s claim that the device did not work was substantiated.The device was received in what appears to be a used condition, the residue was unknown.The device had good continuity but failed capacitance test and connection check.Further investigation of the failed capacitance value found that the capacitor had become detached from the pcb.There is some residue on the capacitor.From our investigation we have determined the cause of the failure to be defective component due to the surface mount capacitor becoming detached from the pcb.A capa has been requested for further investigation.Based on the risk assessment of the capa, the severity risk category is ¿minor¿- results in temporary injury or impairment not requiring professional medical attention.For failure modes that are equivalent to the reported complaint failure mode is system units\system unit features do not function\stop functioning during use.Due to the low failure occurrence rate, minor risk and user/patient no corrective action is deemed necessary at this moment in time.At this point in time, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in that during an unknown surgery on an unknown date, it was observed that the device was.During in-house engineering evaluation, it was determined that there was a residue around the active tip and ceramic on the device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.The device was brand new and the first use when the issue occurred.

• Brand Name: VAPR 3.5MM SIDE STR -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: 12532602
• Report Number: 1221934-2021-02799
• Device Sequence Number: 19202180
• Product Code: GEI
• UDI-Device Identifier: 10886705009251
• UDI-Public: 10886705009251
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Model Number: 225301
• Device Catalogue Number: 225301
• Device Lot Number: U2009064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1