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

Model Number 228147

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Full thickness (Third Degree) Burn (2696); No Code Available (3191)

Event Date 07/19/2019

Event Type  Injury  

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.(b)(4).

Event Description

It was reported by affiliate via email that during the use in a knee arthroscopy, the vapr device cause a significant heat development of the saline that leaked out from the drainage tube of the handle piece.The temperature was so high to cause a 3rd degree burn to the leg in contact with the tube.The skin burn was detected at the end of the surgery the skin lesion has been mediated.The patient was informed and she has a burn skin scar.Patient subjected to skin sampling for transplantation.The device is not available to be returned for evaluation.Additional information provided by the affiliate reported the patient underwent plastic surgery with a skin flap.It was also reported the patient is currently cured and presented effects of an aesthetic cutaneous nature.The affiliate reported no additional treatments planned for this patient and reported the vapr was used in some phases of an arthroscopic routine knee surgery for meniscal and chondral pathology, without intraoperative complication.

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (u1808015), 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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number (u1808015), and no non-conformances were identified.

Manufacturer Narrative

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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the patient underwent plastic surgery with a skin flap.It was reported that the patient was cured and presented effects of an aesthetic cutaneous nature.It was reported that there were no additional treatments planned for this patients.It was reported that the vapr was used in some phases of an arthroscopic routine knee surgery for meniscal and chondral pathology, without intraoperative complication.

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.Subsequent follow-up with the customer, additional information was received regarding the event.It was reported that on (b)(6)2019, the patient was subjected to a right knee surgery due to rupture of the lateral meniscus.Following this surgery, the patient reported a severe skin lesion in the supero-medial third of the right leg, subsequently treated on an outpatient basis on (b)(6)2019, (b)(6)2019 and (b)(6) 2019 without positive healing results.The patient was referred to the large burn center where the patient was hospitalized on (b)(6) 2019 and underwent an autograft of medium-thickness skin taken from the lateral surface of the right thigh.Patient was discharged.After one month, because of painful symptoms and perimetric increase in the right leg, the patient underwent a venous doppler from which acute partial venous thrombosis emerged.

• 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
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10002492
• MDR Text Key: 189153185
• Report Number: 1221934-2020-01247
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 228147
• Device Catalogue Number: 228147
• Device Lot Number: U1808015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female