MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR CLPLSE90 ELECTRODE W HAND CNTRLS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 228147

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported by the sales rep in israel that during an arthroscopic latarjet procedure on an unknown date, it was observed that the metal disc on the tip of the coolpulse 90 electrode with hand controls device detached inside the patient and was not removed.It was unknown how the procedure was completed.The status of the patient was unknown.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: udi: (b)(4).E3: reporter is a j&j sales representative.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.

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.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.Investigation summary the vapr clplse90 electrode w hand cntrls was returned to manufacturer for evaluation.The manufacturer conducted visual inspection of device received by customer.The visual inspection of the device was performed, as a result; device has not been returned in the original packaging.The device was returned with the active tip missing.The plug has been cut off.Handle was in good condition.The functional and electrical test were not performed due to device condition.A device history review (dhr) review has been performed for this lot; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Visual investigation of the reported device, has conclude that the suction tube has been highly eroded resulting from the device being used for a long period of time causing the active tip detachment.The failure mode has been reviewed against the systems risk assessment document 892007-dv, line 450 of the risk analysis matrix applies with a similar failure mode -components / fragments detach within the patient and require retrieval- has been used.This could lead to a potential tissue damage (mechanical).The severity is categorized as "serious" and the pre and post mitigation risk characteristics are as follows: risk grid "14" which is alra (as low as reasonably achievable) level and "probable" occurrence (<10¯3 and =10¯4).This issue has been escalated to a capa.The potential root cause(s) for this type of tip failure was identified as: the weld bridge on active suction tube is not providing sufficient weld material and retention.Mechanical fatigue due to stress corrosion pitting / corrosion and due to welding process.Misuse, (e.G.Extended activation or overloading of mechanical forces).Based on the evidence of the suction tube erosion, the root cause can be attributed to extended use (misuse), therefore, this complaint was confirmed.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: VAPR CLPLSE90 ELECTRODE W HAND CNTRLS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17643161
• MDR Text Key: 322189907
• Report Number: 1221934-2023-03205
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K113545
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228147
• Device Lot Number: U2301046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2023
• 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
• Patient Outcome(s): Required Intervention