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

Model Number	ETRIO335H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.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 gastrectomy, the surgeon closed the jaws outside the patient's body, the handle got stuck and the jaws locked.The blade tip was not broken off and no pieces fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/29/2020.D4: batch #r9373e.Investigation summary: the device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All three tones were heard during functional testing (tone 1 is heard when the energy activation button is pressed; tone 2 is heard when tissue impedance threshold is reached; and tone 3 is heard when the cycle is complete).No issues were noted with opening and closing of the jaws.There were no anomalies noted with the functionality of the device.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• 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
• MDR Report Key: 10062503
• Report Number: 3005075853-2020-02621
• Device Sequence Number: 3697268
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 04/30/2020
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR