MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228146

Device Problem Suction Failure (4039)

Patient Problem Not Applicable (3189)

Event Date 01/01/2019

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).The lot number is unknown.

Event Description

It was reported by the sales rep via phone that during a shoulder arthroscopy the vapr coolpulse90 electrode immediately at start suction did not work, it is not usable.The procedure was completed by using a replacement device with a 5-10 minutes delay.No patient consequences had been reported.Additional information reported could not be provided regarding the lot number or event date.The affiliate did report no patient harm was observed.Two electrode devices were returned to (b)(4) for evaluation.The affiliate confirmed both devices were used in the same procedure and exhibited the same malfunction of suction failure.The affilaiate could not confirm the lot number of the device.

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.The lot number and expiration date were inadvertently missed on the previous report.Therefore, both fields have been updated accordingly to reflect the correct information.Udi: (b)(4).Investigation summary according to the information provided, it was reported by the sales rep via phone that during a shoulder arthroscopy the vapr coolpulse90 electrode immediately at start suction did not work, it is not usable.The complaint device was received.Supplier evaluation result for vapr coolpulse90 electrode: the device was not returned in the original packaging, the active tip looks in a used condition, with evidence of activation and debris on and around the active tip.The suction tube of the device shows evidence of debris/dried saline within, no visible damage to the device shaft, handle, cable or plug.The electrical test was performed with the different parameters (active continuity, return continuity, primary capacitance, and hipot active-return) as a result all pass.During functional test, the activation test ablation and coagulation mode were fail.The device was functional testing using vaprvue generator (gml 4808/3), the test included different values as results the flow rate fail and the activation in ablate and coagulation were pass.Supplier summary: device 2 - the device was electrically and functionally tested.The initial flow rate was found to be 8.14ml/min, well without of specification, substantiating the initial customer complaint.After further evaluation the blockage was confirmed, to be tissue at the distal end of the device.After the blockage was successfully cleared the flow rate was re-measured and found to be well within device specification.For device 2, we were able to confirm the reported suction issue with the returned electrode however no manufacturing defect was found and we have determined the cause of the reported suction blockage to be normal procedural debris within the active tip which was successfully cleared.A manufacturing record evaluation was performed for the finished device u1812038 number, and no non-conformances were identified at this point, 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.

• Brand Name: VAPR COOLPULSE90 ELECTRODE
• 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: 9362236
• MDR Text Key: 208340581
• Report Number: 1221934-2019-59692
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010080
• UDI-Public: 10886705010080
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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: 11/30/2021
• Device Model Number: 228146
• Device Catalogue Number: 228146
• Device Lot Number: U1812038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/03/2020
• Patient Sequence Number: 1