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

Model Number	ETRIO335H
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u9384d.The device was received with no apparent damage.The device was tested on the generator, this resulted in the ¿reposition jaws and reactivate¿ alert screen.The ¿replace instrument¿ alert screen is displayed after receiving three consecutive ¿reposition and reactivate error¿ alert screens and is advising of a potential issue with the instrument.The instrument was disassembled to inspect the internal components and it was noted that the inner hypo tube insulator was missing causing the reposition alert screen received.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.This probably happened in our manufacturing process.
Event or Problem Description
It was reported that during a laparoscopic appendectomy, an error sound was heard 3 times, and ¿replace instrument¿ was displayed during use.The device was reconnected, but the issue did not improve.The device was used on the thin adhesion tissue.The device did not clamp the metal.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 10852073
• Report Number: 3005075853-2020-06062
• Device Sequence Number: 16946513
• 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
• Report Date (Section B): 10/29/2020

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: 02/28/2022
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: U93M09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR