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

Model Number	ETRIO345H
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92y92.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.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 instrument was disassembled and no evidence was found as to what could have contributed to the activation issues.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? sales informed on 9/3/20 that the patient shows no adverse consequences.Did the generator display any error messages and if so what were they? unknown.Did the device pass the pre-test? yes.Had the device been working and then stopped? yes.Did the electrode ceramic separate or break off? examine returned device.Did the i blade get damaged or break off? examine returned device.Is the jaw damaged but not broken off? examine returned device.Is the top jaw loose but not detached? examine returned device.Is the top jaw ptc material damaged? examine returned device.Is the black ptc in the upper jaw detached? examine returned device.Is the top jaw broken off the of the device? no.What efforts were made to locate the missing piece of the jaw? visual inspection during the procedure.
Event or Problem Description
It was reported that during a robotic prostatectomy, an enseal device did not work properly.Potential that a piece of the jaws broke off during use.The piece was not located intra-operatively.The surgeon will explore again when the patient returns to the office, and then the patient will be further examined.Surgery was delayed an unknown amount of time due to this reported event.The second device used to complete the procedure.

• 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: 10641382
• Report Number: 3005075853-2020-05175
• Device Sequence Number: 2438849
• 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): 09/15/2020

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: 03/31/2021
• Device Model Number: ETRIO345H
• Device Catalogue Number: ETRIO345H
• Device Lot Number: T9318F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR