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	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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 urology surgery, there was a problem on the grip of the device and the jaws did not open and close.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: 9/24/2020.D4: batch # t9560z.Investigation summary the device was returned with the jaws misaligned.In addition no handle component issue were noted as reported.Upon inspection under magnification of the jaw it was noted that the retention pins that holds the jaws in position were bent.The device was connected to the generator and it was recognized.Because the jaw was damaged not all functional testing could be performed with the generator.The condition of the jaw prevented the functionality of the device.The instrument was unable to fully 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 retention pins 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.

• 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: 10456362
• Report Number: 3005075853-2020-04355
• Device Sequence Number: 19844707
• 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): 08/04/2020

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: 11/30/2021
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: T9560Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR