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

Catalog Number 228146

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter phone number: (b)(6).(b)(4).Udi: the udi is unknown at this time.

Event Description

It was reported the surgeon used our electrode, but did not observe any abnormal issue in the operation.After operation, took the x-ray, noted one metal piece in the patient, the surgeon suspect this metal piece is from j&j electrode.The electrode code is unknown.The electrode was re-used, but use times is unknown.The patient is stable now.2nd operation date has not been determined yet.Additional information reported by the affiliate reported the date of the additional procedure has not been scheduled.

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.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that it might be two to three months later to have the second surgery performed on the patient for the metal piece to be removed.It was further reported that the device was its first use when it was used.D1, d4, h4: the product code, catalog, lot number, expiration date, manufacture date and udi have been updated accordingly to reflect the correct information.Udi: (b)(4).

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.H10 additional narrative: investigation summary: according to the information provided, it was reported that the surgeon used our electrode, but did not observe any abnormal issue in the operation.After operation, took the x-ray, noted one metal piece in the patient, the surgeon suspect this metal piece is from j&j electrode.The electrode code is unknown.The electrode was re-used, but use times is unknown.The patient is stable now.2nd operation date has not been determined yet.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos of x-ray, can be observed that the active tip of the electrode fell off in the patient.In addition, pictures of the electrode tip, were observed where the hospital disassembled other same product to check if the metal piece which remained in patient is similar as removed, in order to review that the size and shape are very similar.The complaint reported was confirmed.The photo does not provide enough evidence to determine root cause.The impact product was not re-used, it is 1st time used.The possible root cause for the reported failure can be attributed to overloading of mechanical forces.However, it cannot be conclusively affirmed.  a manufacturing record evaluation was performed for the finished device lot number:u1912099, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese 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: 10557511
• MDR Text Key: 207731955
• Report Number: 1221934-2020-02678
• Device Sequence Number: 1
• Product Code: GEI
• 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,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 228146
• Device Lot Number: U1912099
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/25/2020; 10/30/2020
• Supplement Dates FDA Received: 09/28/2020; 11/02/2020
• Patient Sequence Number: 1