MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 GENERATOR; ELECTROSURGICAL SYSTEM GENERATOR

Model Number	225021
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device did not turn on.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: membrane panel is faulty, broken connector pin.The device was diagnosed and resolved with spare parts.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that preoperatively to an unknown procedure on an unknown date, it was observed that the generator device did not turn on.During in-house engineering evaluation, it was determined that the device had broken connector pin.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VAPR3 GENERATOR
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11726929
• Report Number: 1221934-2021-01319
• Device Sequence Number: 3549944
• Product Code: GEI
• UDI-Device Identifier: 10886705009107
• UDI-Public: 10886705009107
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113545
• 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): 04/26/2021

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: 225021
• Device Catalogue Number: 225021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1