MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL TRIO 3MM CURVE TIP 25CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ETRIO325H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
Event or Problem Description
It was reported that during a laparoscopic ovarian cystectomy, the jaws became not to open before use for the patient.There is no possibility that it had forgotten to unlock the safety lock.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• Brand Name: ENSEAL TRIO 3MM CURVE TIP 25CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8793677
• Report Number: 3005075853-2019-20431
• Device Sequence Number: 14230482
• Product Code: GEI
• UDI-Device Identifier: 10705036000280
• UDI-Public: 10705036000280
• Combination Product (Y/N): N
• PMA/510(K) Number: K072177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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 Catalogue Number: ETRIO325H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1