MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM END 21 DEG -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number	225304
Medical Device Problem Codes	Break (1069); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot number is not currently available.
Event or Problem Description
It was reported that the reported device was used during the surgery on (b)(6) 2018.It was noticed that the black coating on the electrode shaft came off during the procedure.Therefore, the surgeon stopped using the reported device.It was brand new and the first use when the issue occurred.There was no delay in surgery and no harm to the patient.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial and first follow-up medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is not currently available.
Event or Problem Description
It was reported that the reported device was used during the surgery on (b)(6) 2018.It was noticed that the black coating on the electrode shaft came off during the procedure.Therefore, the surgeon stopped using the reported device.It was brand new and the first use when the issue occurred.There was no delay in surgery and no harm to the patient.Additional information from affiliate: when did the breakage occur? during te surgery.Did the breakage result in surgical delay of greater than 30 minutes or an inability to complete the procedure as intended? no.If breakage occurred near surgical site, how were fragments retrieved? n/a.How was the procedure completed? no further information was provided.Were alternatives readily available? no.Were there any procedural or patient anatomy factors which may have contributed to the breakage? no.Is surgical intervention planned? no.Did portion of the device remain in the patient? no.Any patient impact? no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.The device shows signs of activation.Visually the black coating was discovered torn distal to the active tip, thus confirming this complaint.The device was tested to determine functionality.The device was connected with an electrode-connector cable with no issue.The device was recognized by the generator, all default settings were present.Using a test footswitch both ablate and coagulate functioned as intended.The observed torn coating from the device could be from aggressive use, the device has a 21-degree angle at the distal tip and only that section of the shaft has the torn material.No indication of any torn material particles being left in the patient.There is no specific root cause that could be determined at this time, however a possible root cause could be that the user had difficulty entering the device into the cannula and made attempts to force push the electrode through, or the device was out of scope during use and the device was pressing against a hard/sharp object.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review into the depuy mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.And at this 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.Udi: (b)(4).

• Brand Name: VAPR 3.5MM END 21 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: 7394036
• Report Number: 1221934-2018-50402
• Device Sequence Number: 1095176
• Product Code: GEI
• UDI-Device Identifier: 10886705009282
• UDI-Public: 10886705009282
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 225304
• Device Lot Number: U1708035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/01/2018; 05/11/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 04/23/2018; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1