MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM HOOK 90 DEG -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number	225305
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(b)(4).The lot number is unknown at this time.
Event or Problem Description
It was reported that this was an arcr (arthroscopic rotator cuff repair) performed on (b)(6) 2020.When the surgeon used the electrode for a relatively long time during the procedure, contact failure occurred.The surgeon was not much concerned about the temperature of reflux fluid.It was postoperatively found that the patient had suffered from mild burn around the lesion area.The device was brand new and the first use when the issue occurred.We went attention to the sales rep to comply with the prescribed reporting date.Note: this (b)(4) are separate cases with the similar nature of the event.
Additional 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 an ointment was postoperatively applied to the patient's mild burn.The patient recovered without a scar.It was reported that the output on the electrode was at the lowest while in use.So, the surgeon instructed to turn up to the maximum.For upcoming use, the sales rep advised the surgeon as follows: a) make sure the main unit is in operation.B) next, connect an electrode to the main unit.
Additional 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 : 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.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

• Brand Name: VAPR 3.5MM HOOK 90 DEG -EA
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10813980
• Report Number: 1221934-2020-03383
• Device Sequence Number: 1768309
• Product Code: GEI
• UDI-Device Identifier: 10886705009299
• UDI-Public: 10886705009299
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 225305
• Device Catalogue Number: 225305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 01/03/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/20/2020; 01/04/2021
• Patient Sequence Number: 1