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

Model Number	ETRIO345H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #u93552.Investigation summary: the device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.In addition the electrode and ceramic were not separated as reported.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.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 complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a hiatal herniorraphy, the distal tip of the enseal felt to have broken off.Surgery was not delayed due to the time reported event.The case was successfully completed.No patient complications.

• 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 ; * 00969
• MDR Report Key: 10459074
• Report Number: 3005075853-2020-04376
• Device Sequence Number: 11567718
• 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): 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: ETRIO345H
• Device Catalogue Number: ETRIO345H
• Device Lot Number: U93552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.