MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR CLPLSE90 ELECTRODE W HAND CNTRLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number 228147

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 Description

It was reported by the healthcare professional via email that the vapr clplse90 electrode w hand cntrls it´s only making bubbles, no ablations or suction.This failure was found at the beginning of the procedure.No additional information has been provided.Additional information received from the affiliate reported a surgical delay of 3 minutes in order to retrieve an alternative device.There were no reported patient consequences or user impact due to the surgical delay.The affiliate also reported the rotator cuff repair was completed with a second vapr electrode which was hooked up to wall suction.It was reported that the malfunctioning device was not re-used or re-processed.The affiliate reported additional surgical intervention was not required.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Investigation summary : the complaint device was received and evaluated.Visual inspection reveals the device to be in a used condition.The active tip shows evidence of activation and debris on and around the active tip as well as the suction port of the device.No visible damage to the device shaft, handle, cable or plug.When tested for functionality, the device functions as intended with no anomalies identified.The device was sent to the manufacturer for further investigation.The manufacturer reported that the initial complaint stated that the user did not have ¿ablation or suction¿ and was only ¿making bubbles¿ cannot be replicated.The device passed all electrical testing and activated with no issues in ablate and coagulation modes.The suction flow of the device was measured pre and post activation and was found to be out of specification, confirming the initial customer complaint.Evaluation of the device showed that the restriction in flow was located at the distal tip of the device.The restriction was could not be removed, therefore the device remained blocked.As no manufacturing issues were found, the likely root cause of the reported suction blockage was determined to be normal procedurel debris within the active tip which could not be removed during testing of the device.The product instruction for use (ifu) cautions not to allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.Furthermore, 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 complaint is required.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 CLPLSE90 ELECTRODE W HAND CNTRLS
• 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: 9344260
• MDR Text Key: 207391131
• Report Number: 1221934-2019-59604
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 228147
• Device Lot Number: U1811159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/16/2020
• Patient Sequence Number: 1