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

Model Number 225024

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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).Investigation summary: the device was received and evaluated at the service center.The device was returned unwanted by the customer without any allegation of malfunction against the same.However it was found that the device had a broken fascia and dent on the keypad membrane, hence this complaint can be confirmed.The device was also missing the dust cover.The damaged parts required replacement for the device to function according to the specifications.The service of the device was however declined and was placed into long-term hold as it was not needed for the equipment exchange pool use.The physical damage to the device and the missing dust cover are most likely a result of user mishandling of the device or a possible fall.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.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 Description

It was reported that the generator device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the device had broken fascia and dent on the keypad membrane.There was no procedure involved.No additional information was provided.

• Brand Name: VAPR VUE GENERATOR
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11087560
• MDR Text Key: 224792726
• Report Number: 1221934-2020-04104
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009121
• UDI-Public: 10886705009121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225024
• Device Catalogue Number: 225024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1