MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL TRIO 3MM CURVE TIP 35CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ETRIO335H
Medical Device Problem Codes	Device Alarm System (1012); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u9397f.The device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.Due to the condition of the device a reposition jaws and reactivate alert screen could be displayed during the procedure.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.Additional information was requested, and the following was obtained: did the patient suffer any adverse consequences? there were no adverse consequences for the patient.
Event or Problem Description
It was reported that during a diagnostic laparoscopy, the product kept giving the message reposition jaws and try again.Handle for jaws wouldn't close.Opened a harmonic to complete the case.It is unknown if there were any patient complications.

• Brand Name: ENSEAL TRIO 3MM CURVE TIP 35CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10874988
• Report Number: 3005075853-2020-06159
• Device Sequence Number: 16957614
• Product Code: GEI
• UDI-Device Identifier: 10705036000297
• UDI-Public: 10705036000297
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: 01/31/2025
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: U94E4G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR