MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL VAPR COOLPULSE CURVE SUCTION ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 225031

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/25/2023

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: udi:(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.

Event Description

This is report 1 of 2 for (b)(4).It was reported by the healthcare professional in switzerland that during a hip scope procedure on (b)(6) 2023, it was observed that the vapr coolpulse curve suction electrode device clogged-up, and thus blocking the suction after around 10 minutes of use.Changed to another one to continue the procedure but clogged-up the first time after 5 to 10 minutes of use.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.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.H10 additional narrative: investigation summary: the device was received and evaluated.Visual inspection revealed that the device shaft was slight bent, the tip shows activation signs, the suction tube as well as the connector pins were in a normal condition.To test its functionality the device was connected to the generator, the ablation function was activated and an output shorted message was displayed.Coagulation was activated and the same issue was detected.The electrode will be sent to the supplier for evaluation.Two devices were received, the coolpulse curve was returned to the manufacturer for evaluation.The manufacturer conducted visual inspection and functional test of the device received by customer.Visual inspection, electrical and functional test for the first device were performed, visual inspection reveled that the device was returned in the box, device in used condition, tissue debris visible in suction holes, residue visible in suction tube, device shaft distorted.The electrical hipot test was not passed as well as the flow test.No issues (ncr or deviations) with the manufacturing process have been found in the devices that might explain any possible observed failures.The customer claimed during surgery the cp curve xl electrode clogs and thus blocks the suction after 10 minutes and the cp curve clogs for the first time after 5 to 10 mins.The testing confirmed that both devices were blocked.The blockage could not be freed and was located at the distal end of the device behind the active tip.It was noted in the customer report that the suction was applied by a stryker neptune unit and a suction flow rate of 80mm/hg.This suction flow rate is below the recommend minimum value of 300mm/hg as stated in the ifu.Reported device was evaluated by alt uk team coolpulse curve device failed the flow tests and the hipot test while still performing activation for both, ablate and coag.The source of these failures is attributable to the restrictions located in the active tip, caused by tissue debris.In the coolpulse curve's case, the failure of the hipot test, with no output short warning and coag and ablation activation happening, indicates that it has been inducted by the debris presence as well.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

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.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.The assignable root cause for reported failures of suction failure and off lable use was determined to be traced to user, which is user error.The assignable root cause for reported failure of foreign substance/debris/cleaning/sterilisation was determined to be traced to user, which is user error.

• Brand Name: VAPR COOLPULSE CURVE SUCTION ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17474717
• MDR Text Key: 320621199
• Report Number: 1221934-2023-02968
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705027958
• UDI-Public: 10886705027958
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K143475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225031
• Device Lot Number: U2109109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1