MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL TRIO 3MM CURVE TIP 45CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ETRIO345H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #.Investigation summary: the device was received with no apparent damage.The device was tested on the generator, this resulted in the ¿close jaws on tissue and reactivate¿ alert screen, and this is advising the generator cannot deliver energy.Then the "replace instrument" screen would be displayed after receiving the "close jaws on tissue and reactivate" message twice.The instrument was disassembled to inspect the internal components and it was noted that the limit switch button was damaged.No conclusion could be reached as to what caused this issue.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during a bariatric procedure the surgeon did not get the final notification that he had burned and transected the tissue.He opened a second device and had the same issue.He completed the procedure with the second device.There were no adverse patient consequences.

• Brand Name: ENSEAL TRIO 3MM CURVE TIP 45CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8972479
• Report Number: 3005075853-2019-21794
• Device Sequence Number: 16913941
• Product Code: GEI
• UDI-Device Identifier: 10705036000303
• UDI-Public: 10705036000303
• Combination Product (Y/N): N
• PMA/510(K) Number: K072493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: 03/31/2020
• Device Catalogue Number: ETRIO345H
• Device Lot Number: R92Y9Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1