MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR TRIPOLAR 90 SUCTION ELECT; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225028

Device Problems Use of Device Problem (1670); Infusion or Flow Problem (2964); Suction Failure (4039)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Udi: (b)(4).

Event Description

It was reported by affiliate via email that during its use, the electrode didn't work, the electrode didn't aspirate.Another device (another lot) was successfully used.No patient impact.This incident occurred twice: the first issue was recorded under the (b)(4) and the second issue was recorded under the (b)(4).The device was discarded.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during a shoulder arthroscopy (rotator cuff) procedure.There was a ten minute delay in the procedure.There were no patient consequences or impact to the user or patient.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Investigation summary: according to the information provided, it was reported that the electrode did not work, the electrode did not aspirate.The complaint device was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [u2003068] number, and no non-conformances were identified.At this point in time, no corrective action is required, and 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.Udi: (b)(4).

• Brand Name: VAPR TRIPOLAR 90 SUCTION ELECT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10760111
• MDR Text Key: 214148507
• Report Number: 1221934-2020-03252
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705023103
• UDI-Public: 10886705023103
• Combination Product (y/n): N
• PMA/PMN Number: K143475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 225028
• Device Catalogue Number: 225028
• Device Lot Number: U2003068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1